Class I recalls
Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
CareFusion 209 Inc. | Jan-26-2012 | NicoletOne Software – NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License; Catalog/Part Number: 828-056600Product Usage:The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors; providing stimulation via electrode pairs or a hand held bipolar probe. | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes. Also; it has been determined that the stimulus cable connection in the Cortical S |
CareFusion 209 Inc. | Jan-26-2012 | Nicolet Cortical Stimulator Control Unit; – Nicolet Cortical Stimulator Control Unit; Catalog/Part Number: 982A0558Product Usage:The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors; providing stimulation via electrode pairs or a hand held bipolar probe. | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes. Also; it has been determined that the stimulus cable connection in the Cortical S |
CareFusion 209 Inc. | Jan-26-2012 | Nicolet C64 Stimulus Switching Unit (SSU Amplifier); – Nicolet C64 Stimulus Switching Unit (SSU Amplifier); Catalog/ Part Numbers: 382-610800; 688-624200; 688-624300; 842-687900; 672-610800F.Product Usage:The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors; providing stimulation via electrode pairs or a hand held bipolar probe. | CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes. Also; it has been determined that the stimulus cable connection in the Cortical S |
Nellcor Puritan Bennett Inc. (dba Covidien LP) | Jan-26-2012 | BIS BILATERAL SENSOR – BIS Bilateral Sensors; part number 186-0212; packaged in boxes of 10. For use with BIS Monitoring System; Labeled as either Covidien Llc; or Aspect Medical Systems; Inc.Product Usage:To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use; disposable; pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended. | During manufacture; circuit traces were reversed which causes inaccurate display of information. |
SALTER LABS | Jan-26-2012 | Salter Labs Bubble humidifier – Salter Labs Bubble humidifier; with 6 PSI safety valve; 350cc; Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50; E7600-0-50; NP7600-0-50 and special order patient kits that contain 7600 humidifiers. Patient kits have brand names of Salter Labs; AdvaCare; Allcare Medical; Memorial Home Services; Therapy Support Inc; Mendo-Lake Home Respiratory Services; MedAssurance Inc.; Abundant Home Care.Product Usage: Humidifier – single patient use. used with supplemental oxygen therapy. | A manufacturing defect was discovered internally which indicates that in a small number of humidifier lids; the pop-off may not occur at the appropriate pressure and can result in a leak. |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Aire-Cuf Pediatric Tracheostomy Tube – Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 – 5.5Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Uncuffed Neonatal Tracheostomy Tube – Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 – 4.0 (With a V-Shaped Neck Flange) | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Uncuffed Pediatric Tracheostomy Tube – Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 – 5.5 (With a Straight Neck Flange)Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Uncuffed Pediatric Tracheostomy Tube – Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 – 5.5 (With a V-Shaped Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona TTS Cuffed Pediatric Tracheostomy Tube – Bivona TTS Cuffed Pediatric Tracheostomy TubeSizes 2.5 – 5.5 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona TTS Cuffed Pediatric Tracheostomy Tube – Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 – 5.5 (With a V-Shaped Neck Flange)Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona TTS Cuffed Neonatal Tracheostomy Tube – Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 – 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona TTS Cuffed Neonatal Tracheostomy Tube – Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 – 4.0 (With a V-Shaped Neck Flange). | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Uncuffed Neonatal Tracheostomy Tube – Bivona Uncuffed Neonatal Tracheostomy TubeSizes 2.5 – 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Aire-Cuf Pediatric Tracheostomy Tube – Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 – 5.5Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube – Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 – 4.0 (With a V-Shaped Neck Flange)Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube – "Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 – 4.0 (With a Straight Neck Flange)Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube – Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 – 5.5 (With a V-Shaped Neck Flange)Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube – Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 – 5.5 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube – Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 – 6.0 (With a V-Shaped Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Smiths Medical ASD; Inc. | Jan-19-2012 | Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube – Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 – 6.0 (With a Straight Neck Flange)Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse. | Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed Neonatal; Pediatric and Flextend Tracheostomy Tubes TR3 connector; which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory; this may result in decannulation of the tube which could result in serious injury or death; |
Carefusion 211 Inc | Jan-11-2012 | AVEA Ventilator – AVEA Ventilator (Catalog Code 17310; 17311; 17312).The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel; under the direction of a physician. Prescription Use: Federal law restricts the sale of this device except by or on order of a physician. | The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1; 2009 and June 30; 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk. |
Ino Therapeutics | Jan-11-2012 | INOmax DS (Delivery System) – INOmax DS (Delivery System) Model 10003 & 10007.The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO); as set by the user; to the patient throughout the inspired breath. It uses a specially designed injector module; which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2; NO2; and NO; and a comprehensive alarm system. | Through the review and monitoring of its complaint data; Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA; it was concluded that the action should have been reported under 21 CFR & 806.10. |
Respironics; Inc. | Jan-11-2012 | Respironics Trilogy 100; 200 and 202 Ventilators – Trilogy 100; 200 and 202 VentilatorsThe device is intended to be used in home; institution/hospital; and portable applications such as wheelchairs and gurneys; and may be used for both invasive and non-invasive ventilation. | Trilogy 100; 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough; theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy. |
St Jude Medical CRMD | Jan-11-2012 | Riata ST Silicone Insulated Leads – St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr); Models: 7000; 7001; 7002; 7010; 7011; 7040; 7041; 7042 Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy. | The recall was initiated because St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors. |
St Jude Medical CRMD | Jan-11-2012 | Riata – St. Jude Medical Riata (8Fr); Models: 1560; 1561; 1562; 1570; 1571; 1572; 1580; 1581; 1582; 1590; 1591; 1592Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy. | The recall was initiated because St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors. |
Coopervision Inc. | Jan-11-2012 | AVAIRA (enfilcon A) Daily Wear Sphere Contact Lens – AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposable); Rx only; STERILE — CooperVision: Hamble; SO31 4RF; UK — Scottsville; NY 14546 USA — Juana Diaz; PR 00795 USA — Device Listing # D033736. Packaged: 6 Soft Contact Lenses per unit carton or trial product 3 pack.AVAIRA (enfilcon A) SPHERE soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. | Presence of silicone oil residue on Avaira Sphere Soft Contact Lenses. |
Class II recalls
Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
Stryker Howmedica Osteonics Corp. | Jan-30-2012 | Stryker – Duration packaging distributed byStryker Orthopaedics; Limerick; IrelandStryker IrelandCarrigtwohill Industrial EstateCarrigtwohill County Cork; IrelandProduct Usage:Orthopaedic implants utilized for primary and revision hip and knee (total and unilateral); total shoulder and elbow replacement; replacement; and oncological surgical procedures related to tumor resection. All devices are manufactured from UHMWPE and are processed through post-sterilization (gamma irradiation) heat treatment for stabilization (i.e. Duration process). Launched in 1996; Duration Stabilized Polyethylene is produced by a patented process utilizing a combination of nitrogen packaging to reduce shelf oxidation; gamma irradiation (3Mrads) to sterilize and crosslink the polyethylene; and a post-irradiation stabilization step during which the components undergo a heat treatment process to promote further crosslin king and to enhance product wear resistance. In order to maintain the nitrogen environment over the shelf-life of the product; the packaging consists of double; nested PET blisters sealed with foil (non-gas permeable) Iidstock. | As part of Stryker?’s quality process; a packaging discrepancy was identified in specific lots of Stryker?’s Duration? packaging. |
DePuy Orthopaedics; Inc. | Jan-30-2012 | SIGMA HP Fixed Bearing Tibial Tray Impactor – The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of the PFC SIGMA Knee. SIGMA HP Fixed Bearing Tibial Tray Impactors Packaged in poly bag with optional protection from sharp or fragile points; distributed by DePuy International Leeds; UK. Instruments are supplied non-sterile and do not have specified expiration date or shelf life.Usage: The Tibial Tray (with protective cover) and instrument are assembled outside of the patient in theatre; the tray is introduced and impacted into the cement containing tibia using the impactor. Once the tray is fully seated in the cement containing tibia; the instrument is intended to be removed. | All lots of DePuy; SIGMA HP Fixed Bearing Tibial Tray Impactors are being recalled because the impactor can become intentionally locked on the Tibial Tray implant during surgery. |
Beckman Coulter Inc. | Jan-30-2012 | Access Immunoassay Systems – Access Immunoassay Systems Part Number: 81600Access 2 Immunoassay Systems Part Number: 81600NAccess Immunoassay Systems LXi 725 Part Number: 386200Subsequent Product Codes: JGSThe Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. | The recall was initiated because certain Access immunoassays can produce inaccurate results when performed within the published UniCel DxI Immunoassay Systems* room temperature operating specification of 18 degrees C to 32 degrees C (64.4 degrees F to 89.6 degrees F). An increase in room temperature causes assay results for some assays to decrease; while results for other assays increase with an i |
Beckman Coulter Inc. | Jan-30-2012 | UniCel DxI 800 Access Immunoassay Systems – UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100UniCel DxI 600 Access Immunoassay Systems Part Numbers: A30260UniCel DxC 600i; SYNCHRON Access Clinical Systems Part Numbers: A25656UniCel DxC 660i; 680i; 860i; 880i SYNCHRON Access Clinical Systems Part Numbers: A64871; A64903; A64935; A59102Subsequent Product Codes: CEMThe Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. | The recall was initiated because certain Access immunoassays can produce inaccurate results when performed within the published UniCel DxI Immunoassay Systems* room temperature operating specification of 18 degrees C to 32 degrees C (64.4 degrees F to 89.6 degrees F). An increase in room temperature causes assay results for some assays to decrease; while results for other assays increase with an i |
Vision-Sciences; Inc. | Jan-29-2012 | Vision Sciences Battery – Product is a lithium ion battery sold as both a stand-alone accessory; and as part of endoscopy system sets. Stand alone labeling: Vision Sciences Rechargeable Lithium Ion Batteries; Replacement (2) [REF] 07-3052; [MFG Symbol] Vision-Sciences; Inc.; 40 Ramland Road South; Orangeburg; NY 10962 USA.Accessory to endoscopy kits used to charge/recharge lithium ion batteries. | Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged. |
Vision-Sciences; Inc. | Jan-29-2012 | Vision Sciences Battery Charger – Product is a lithium ion battery charger sold as both a stand-alone accessory; and as part of endoscopy system sets. — Stand alone labeling: Vision Sciences Battery Charger; Lithium Ion [REF] 07-3051; [MFG Symbol] Vision-Sciences; Inc.; 40 Ramland Road South; Orangeburg; NY 10962 USA.Accessory to endoscopy kits used to charge/recharge lithium ion batteries. | Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged. |
Howmedica Osteonics Corp dba Stryker Craniomaxillofacial | Jan-27-2012 | MEDPOR TITAN – MEDPOR TITAN Cranial Temporal with Template – Right; Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. | The template that is packaged with this implant was not packaged according to specification. The template was packaged in a single pouch instead of a double pouch. |
Cardinal Health | Jan-27-2012 | Presource Custom Sterile Surgical and Procedure Kits – Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health; McGaw Park; IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components:a) Jobri Circumcision Strap; Small; 2 x 8 inch; component part number 086-0001;b) Jobri Circumcision Strap; Large; 2 x 10 inch; component part number 086-0002;The restraint is used to secure an infant during a circumcision procedure.Product Usage:The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant during a circumcision procedure. | The Presource kits were assembled with a Jobri Infant Restraint Strap which does not have the appropriate 510(k) pre-market clearance. |
Novomedicus Llc | Jan-27-2012 | Bur Hypo Pack – The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only.Contents: 1. Large Bur Patch (Sterile: EO); 20cm x 40cm Loop Sheet; 20cm x 40cm Hook Sheet.2. 60cm x 85 cm Steri Drape3. Drain with Connector4. 4 x Gauze RollsCaution: Federal Law restricts this device to sale by or on the order of a physician. Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged.The Wittmann Patch is used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process. | On 06/22/2011 Novomedicus; FL initiated a recall of Wittmann Hypopack Lot 1010.1; 1102.1; 1103.1 and 5643.2. Cytotoxicity testing revealed a biocompatibility issue. The test results did not represent a health risk. |
Novomedicus Llc | Jan-27-2012 | Artificial Bur Fascia Prothesis – The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound Dressing.Contents: Large Bur Patch (Sterile: EO); 20cm x 40cm Loop Sheet; 20cm x 40cm Hook Sheet.Caution: Federal Law restricts this device to sale by or on the order of a physician. Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged.Manufactured For: NOVOMEDICUS; LLC P.O. Box 2105 Nokomis; FL 34274 Phone 941.375.4108 Email:Support@novomedicus.comThe Wittmann Patch is used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process. | On 06/22/2011 Novomedicus; FL initiated a recall of Wittmann Hypopack Lot 1010.1; 1102.1; 1103.1 and 5643.2. Cytotoxicity testing revealed a biocompatibility issue. The test results did not represent a health risk. |
Ortho-Clinical Diagnostics | Jan-27-2012 | VITROS ECiQ Immunodiagnostic System – VITROS ECiQ Immunodiagnostic System; Catalog No. 1922814 — COMMON/USUAL NAME: VITROS ECiQ System — Ortho-Clinical Diagnostics; 100 Indigo Creek Drive; Rochester; NY 14626 — All systems that have Software Version 3.8 or below installed and on which the VITROS Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed.Product Usage:For in vitro diagnostic use only. To perform random access; batch and STAT immunodiagnostic assays on human fluid specimens | Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result; which is accompanied by an Invalid Dilution (ID) code. The diluted results were inconsistent with results from the neat (undiluted) sample; which was within the measuring range of 2.39 – 15;000 mIU/mL. OCD’s investigati |
Catch Incorporated | Jan-27-2012 | Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method – Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method. Catalog Number E02-057-02.A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia. | Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had prematurely decayed. |
Ortho-Clinical Diagnostics | Jan-27-2012 | VITROS ECi Immunodiagnostic System – VITROS ECi Immunodiagnostic System; Catalog No. 8633893 — COMMON/USUAL NAME: VITROS ECi System — Ortho-Clinical Diagnostics; 100 Indigo Creek Drive; Rochester; NY 14626 — All systems that have Software Version 3.8 or below installed and on which the VITROS Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage:For in vitro diagnostic use only. To perform random access; batch and STAT immunodiagnostic assays on human fluid specimens | Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result; which is accompanied by an Invalid Dilution (ID) code. The diluted results were inconsistent with results from the neat (undiluted) sample; which was within the measuring range of 2.39 – 15;000 mIU/mL. OCD’s investigati |
Cardinal Health | Jan-27-2012 | Presource Custom Sterile Surgical and Procedure Kits – Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health; McGaw Park; IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components:a) Jobri Circumcision Strap; Small; 2 x 8 inch; component part number 086-0001;b) Jobri Circumcision Strap; Large; 2 x 10 inch; component part number 086-0002;The restraint is used to secure an infant during a circumcision procedure.Product Usage:The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant during a circumcision procedure. | The Presource kits were assembled with a Jobri Infant Restraint Strap which does not have the appropriate 510(k) pre-market clearance. |
Kerr Corporation | Jan-27-2012 | Maxcem Elite; a dental cement – Brand name: Maxcem Elite; Product: a dental cement;Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic; resin and metal-based inlays; onlays; crowns; bridges; posts and veneers. Additional Indications include core-buildup material; pit and fissure sealant and cementation of crown restorations to implants | The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of work?time thereby causing the product to prematurely set by 15 seconds. |
Siemens Medical Solutions USA; Inc | Jan-27-2012 | AXIOM Artis and AXIOM Artis zee modular angiographic systems – AXIOM Artis and AXIOM Artis zee modular angiographic systemsProduct Usage: Angiographic x-ray systems | There is a potential misalignment in the connection of the remote foot switch and the stationary unit. This potential malfunction may occur if either the wireless foot switch or the stationary unit is equipped with improper firmware installed in the bluetooth interface performing the communication between foot switch and system. This is not a general issue but sporadic as a vendor unsystematical |
Ortho-Clinical Diagnostics | Jan-27-2012 | VITROS Chemistry Products DT Calibrator Kit – VITROS Chemistry Products DT Calibrator Kit; REF/Catalog No. 195 7927; IVD — Common/Usual Name: VITROS DT Calibrator Kit — Ortho-Clinical Diagnostics; Inc. Rochester; NY — Ortho-Clinical Diagnostics High Wycombe; UK VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB; ALKP; ALT; AMYL; AST; TBIL; NBIL; BUN/UREA; Ca; CHOL; CK; Cl-; CO2; CREA; CRSC; Fe; GGT; GLU; HDLC; K+; LAC; LDH; LIPA; Mg; Na+; NH3; PHOS; TP; TRIG; urCR; and URIC on VITROS DT Chemistry Systems. | Ortho Clinical Diagnostics (OCD) was notified by customers of negatively biased quality control results obtained while using VITROS? Chemistry Products NBIL DT Slides; GEN 72. OCD performed an internal investigation and confirmed that negatively biased NBIL results could occur for quality control; proficiency and patient samples. As a result; VITROS? Chemistry Products DT Calibrator Kit Lots 37 & |
Angiodynamics Worldwide Headquarters | Jan-27-2012 | NanoKnife – NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator; footswitch; disposable electrode. System is manufactured by AngioDynamics; Inc. — Catalog #20300101Intended use: the generator system with six outputs is indicated for surgical ablation of soft tissue. | Angiodynamics was marketing the NanoKnife System with the ablation zone estimator feature in the US without FDA clearance. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12104605 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Special Order Morpheus Smart PICC CT 65cm 6F Dual Lumen with Reverse Taper — Max CT Flow Rate: 6mL/sec — Injector Pressure Limit — Catalog No.: 52102624 — Made in the USA — [Manufacturer symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper — Max CT Flow Rate: 4mL/sec — Injector Pressure Limit — Catalog No.: 52102618 — Made in the USA — [Manufacturer symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper — Max CT Flow Rate: 4mL/sec — Injector Pressure Limit — Catalog No.: 52100602 — Made in the USA — [Manufacturer symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 6F Triple Lumen w/ Reverse Taper 55cm — Max CT Flow Rate: 5mL/sec — Catalog No.: 12110941 — AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 — Assembled and Packaged in the USA.indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 55cm — Max CT Flow Rate: 5mL/sec — Catalog No.: 12110937 — AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 — Assembled and Packaged in the USA.indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen — Max CT Flow Rate: 4 mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12100805 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102604 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102605 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER — Max CT Flow Rate: 6mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102606 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102611 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER — Max CT Flow Rate: 6mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102613 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 55cm 5F Dual Lumen with REVERSE TAPER — Max CT Flow Rate: 5mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102616 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 55cm 6F Dual Lumen with REVERSE TAPER — Max CT Flow Rate: 5mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102617 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102805 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen — Max CT Flow Rate: 6mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102806 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102812 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102813 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102821 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12102829 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper — Max CT Flow Rate: 4mL/sec — Injector Pressure Limit — Catalog No.: 52102638— Made in the USA — [Manufacturer symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER — Max CT Flow Rate: 6mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12104606 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12104612 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12104805 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12104813 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen — Max CT Flow Rate: 6mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12104814 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen — Max CT Flow Rate: 4mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12104821 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen — Max CT Flow Rate: 6mL/SEC — Injector Pressure Limit: 300 PSI — Catalog No. [REF] 12104830 — Made in the USA — [Manufacturing symbol] AngioDynamics; 603 Queensbury Avenue; Queensbury; NY USA 12804indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen 65cm — Max CT Flow Rate: 4mL/SEC — Catalog No.: 12110904 — AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 — Assembled and Packaged in the USA.indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm — Max CT Flow Rate: 4mL/sec — Catalog No.: 12110917 — AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 — Assembled and Packaged in the USA.indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 6F Dual Lumen w/ Reverse Taper 65cm — Max CT Flow Rate: 6mL/sec — Catalog No.: 12110918 — AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 — Assembled and Packaged in the USA.indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm — Max CT Flow Rate: 4mL/sec — Catalog No.: 12110919 — AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 — Assembled and Packaged in the USA.indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen 65cm — Max CT Flow Rate: 4mL/sec — Catalog No.: 12110923 — AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 — Assembled and Packaged in the USA.indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 65cm — Max CT Flow Rate: 4mL/sec — Catalog No.: 12110929 — AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 — Assembled and Packaged in the USA.indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm — Max CT Flow Rate: 4mL/sec — Catalog No.: 12110934 — AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 — Assembled and Packaged in the USA.indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
Angiodynamics Worldwide Headquarters | Jan-26-2012 | AngioDynamics Morpheus Smart PICC CT – AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 55cm — Max CT Flow Rate: 5mL/sec — Catalog No.: 12110936 — AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY 12804 — Assembled and Packaged in the USA.indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
CareFusion 303; Inc. | Jan-26-2012 | Alaris PC unit – Alaris PC unit model 8015.The Alaris PC unit is the central programming; monitoring and power supply component for the Alaris System. | The recall was initiated because Carefusion has identified a potential risk with a PLD component on the Alaris PC unit model 8015 power supply board. The PLD component used in production between June 21; 2011 and August 15; 2011 has a higher standby current resulting in the battery depleting prematurely. |
Ortho-Clinical Diagnostics | Jan-26-2012 | enGen(TM) Laboratory Automation Systems – enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges; Catalog # enGen — Common/Usual Name: enGen(TM) Track System; Hettich Centrifuge — Ortho-Clinical Diagnostics; Inc. Rochester; NY — For in vitro diagnostic use only.The VITROS 5;1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest; using both VITROS Chemistry Products Slides (colorimetric endpoint; rate; ion-selective electrode; and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods). | Ortho Clinical Diagnostics received complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC Robotic Centrifuges; Models 4815; 4816 and 4817; that may be configured with enGen(TM) Laboratory Automation Systems. |
Cardinal Health | Jan-26-2012 | Presource Custom Sterile Surgical and Procedure Kits – Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health; McGaw Park; IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components: a) Cool Peri-Pad Self-Adhesive Absorbent Pad with Built-In Cold Pack; component C-CP23; vendor part number CP23;b) Giraffe Disposable Skin Temperature Probe; vendor part number 6600-0873-700; | Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product. |
Cardinal Health | Jan-26-2012 | Presource Custom Sterile Surgical and Procedure Kits – Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health; McGaw Park; IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components: a) Silastic Tubing; 0.062 ID x 0.032 Wall x 50 Ft; component C-602-285; vendor part number SFM3-2850; b) Silastic Tubing; 0.040 ID x 0.023 Wall x 50 Ft; component C-SFM3-2050; vendor part number SFM3-2050; c) Pathology Container with Lid; 8 oz.; component 3701Z; vendor part number 3701; d) Silicone Tubing; 0.187 ID x 0.313 OD x 50 Ft.; component C-31010SG; vendor part number 31010; | Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product. |
Stryker Communications Corp | Jan-26-2012 | Visum LED Surgical Lights – Visum LED Surgical Lights; Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures with high intensity light. | Stryker has identified a potential structural issue with the Visum LED surgical light(s). During a complaint investigation; Stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning to separate from the suspension arm. In the event the light separates and falls from the arm; it could lead to serious injury. |
Smith & Nephew Inc. | Jan-26-2012 | Renasys Port – ***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew; Inc.; St. Petersburg; FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456.Product Usage: The product is a suction device used as an accessory to the foam dressing kits; which is used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to a wound. | On 12/14/2010; Smith & Nephew; Inc. Wound Management Division in St. Petersburg; FL recalled their RENASYS PORT product code number 66800694 due to small holes in the primary pouch of some of the packaged units of which constituted a breach of the sterile barrier. |
Church & Dwight Inc | Jan-25-2012 | Spinbrush Pro Clean Re-Charge – Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-ChargeMade in China.Manufactured for Church and Dwight Co.; Inc. Princeton; NJ 08543 USA.For dental health; plaque removal. | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. |
Church & Dwight Inc | Jan-25-2012 | Spinbrush Pro Whitening – Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro WhiteningMade in China.Manufactured for Church and Dwight Co.; Inc. Princeton; NJ 08543 USA.For dental health; plaque removal. | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. |
Zimmer Inc. | Jan-25-2012 | 5100-03-707 Most Option Stem Distractor – 5100-03-707 — MOST Option STEM DISTRACTORMATL: SS NONSTERILE QTY-1Designed to facilitate intraoperative decisions with a variety of options for femoral and tibial components; implant connections and fixation of the implants. | Fractured tips: Any use of force in a certain direction to the flat side of the instrument may result in fracturing of the mating geometry; creating the potential for metal debris at the surgical site. |
Church & Dwight Inc | Jan-25-2012 | Spinbrush Pro-Clean – Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean; various models.Made in China.Manufactured for Church and Dwight Co.; Inc. Princeton; NJ 08543 USA.For dental health; plaque removal. | Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life. |
Stryker Instruments Div. of Stryker Corporation | Jan-25-2012 | Stryker PCD Precision System 13G Needle with Spineplex – Stryker PCD Precision System 13G Needle with Spineplex; sterile; single use; disposable ; 4 units per box. units per box. Stryker Instruments; Kalamazoo; MI Part Number: 0505-585-000; Lot:1122301213G Match Ground Four facet Tip Introduction Needle – PIN 0306-130-01113G Bevel Tip Stylet – PIN 0306-131-012The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy | Product was packaged with a four inch needle in stead of the correct five inch needle. There is a potential that the needle may not be able to reach the fracture site; which may require additional medical intervention. In addition; if the stylet needs to be changed and the additional stylet that comes in the package is used; this additional stylet is one inch longer than the needle. which could l |
Gunnell; Inc. | Jan-25-2012 | Bariatric Rehab Tough & Tilt (BTNT) – Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature; including: Bariatric Rehab Tough & Tilt (BTNT) Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital; nursing home or extended care facility. | Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position; or as described by users; the back support or canes were spongy in the Rehab Tough and Tilt (TNT); Bariatric Rehab Tough and Tilt (BTNT); Rehab Recline and Mobility (RAM); Bariatric Rehab Recline and Mobility (BRAM); and Rehab Kidster. |
Gunnell; Inc. | Jan-25-2012 | Rehab RAM – Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature; including: Rehab RAMProduct Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital; nursing home or extended care facility. | Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position; or as described by users; the back support or canes were spongy in the Rehab Tough and Tilt (TNT); Bariatric Rehab Tough and Tilt (BTNT); Rehab Recline and Mobility (RAM); Bariatric Rehab Recline and Mobility (BRAM); and Rehab Kidster. |
Gunnell; Inc. | Jan-25-2012 | Rehab Kidster ( Kidster) – Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature; including: Rehab Kidster( Kidster). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital; nursing home or extended care facility. | Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position; or as described by users; the back support or canes were spongy in the Rehab Tough and Tilt (TNT); Bariatric Rehab Tough and Tilt (BTNT); Rehab Recline and Mobility (RAM); Bariatric Rehab Recline and Mobility (BRAM); and Rehab Kidster. |
Gunnell; Inc. | Jan-25-2012 | Rehab Tough and Tilt (TNT) – Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature; including: Rehab Tough and Tilt (TNT). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital; nursing home or extended care facility. | Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a firm position; or as described by users; the back support or canes were spongy in the Rehab Tough and Tilt (TNT); Bariatric Rehab Tough and Tilt (BTNT); Rehab Recline and Mobility (RAM); Bariatric Rehab Recline and Mobility (BRAM); and Rehab Kidster. |
Gunnell; Inc. | Jan-25-2012 | Rehab MAC Platform Chair – Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature; including: Rehab MAC Platform ChairProduct Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital; nursing home or extended care facility. | Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs with dynamic recline would not hold a firm position; or as described by users; the back support or canes were spongy. |
Steris Corporation Hopkins Facility | Jan-25-2012 | SYSTEM 1E Liquid Chemical Sterilant Processing Systm – STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500; 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462; cleared 9/2/2010; add to file 2/24/2011.The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices; including endoscopes and their accessories. | Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality; water pressure and water temperature. Failure to meet these criteriae may lead to cycle aborts by the SYSTEM 1E Liquid Chemical Sterilant Processing System. The firm intends to perform a software field correction which |
Zimmer Inc. | Jan-25-2012 | Natural-Knee II Durasul All-Poly Patella; Size 2; 10mm – Natural-Knee II Durasul All-Poly Patella; Size 2; 10mmThe Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral; tibial; articular surface; and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD); e.g.; avascular necrosis; osteoarthritis; and inflammatory degenerative joint disease (IJD); e.g.; rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain; deformity; or dysfunction persists; and revision of previously failed knee arthroplasty. | The firm has 16 reports of patella peg shear out of 109;386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene; Durasul; patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used |
Zimmer Inc. | Jan-25-2012 | Natural-Knee II Durasul All-Poly Patella; Size 1; 10mm – Natural-Knee II Durasul All-Poly Patella; Size 1; 10mmThe Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral; tibial; articular surface; and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD); e.g.; avascular necrosis; osteoarthritis; and inflammatory degenerative joint disease (IJD); e.g.; rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain; deformity; or dysfunction persists; and revision of previously failed knee arthroplasty. | The firm has 16 reports of patella peg shear out of 109;386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene; Durasul; patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used |
Zimmer Inc. | Jan-25-2012 | Natural-Knee II Durasul All-Poly Patella; Size 0; 10mm – Natural-Knee II Durasul All-Poly Patella; Size 0; 10mmThe Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral; tibial; articular surface; and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD); e.g.; avascular necrosis; osteoarthritis; and inflammatory degenerative joint disease (IJD); e.g.; rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain; deformity; or dysfunction persists; and revision of previously failed knee arthroplasty. | The firm has 16 reports of patella peg shear out of 109;386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene; Durasul; patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used |
Zimmer Inc. | Jan-25-2012 | Natural-Knee II Durasul All-Poly Patella; Size 3; 7mm – Natural-Knee II Durasul All-Poly Patella; Size 3; 7mmThe Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral; tibial; articular surface; and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD); e.g.; avascular necrosis; osteoarthritis; and inflammatory degenerative joint disease (IJD); e.g.; rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain; deformity; or dysfunction persists; and revision of previously failed knee arthroplasty. | The firm has 16 reports of patella peg shear out of 109;386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene; Durasul; patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used |
Zimmer Inc. | Jan-25-2012 | Natural-Knee II Durasul All-Poly Patella; Size 2; 7mm – Natural-Knee II Durasul All-Poly Patella; Size 2; 7mmThe Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral; tibial; articular surface; and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD); e.g.; avascular necrosis; osteoarthritis; and inflammatory degenerative joint disease (IJD); e.g.; rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain; deformity; or dysfunction persists; and revision of previously failed knee arthroplasty. | The firm has 16 reports of patella peg shear out of 109;386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene; Durasul; patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used |
Zimmer Inc. | Jan-25-2012 | Natural-Knee II Durasul All-Poly Patella; Size 1; 7mm – Natural-Knee II Durasul All-Poly Patella; Size 1; 7mmThe Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral; tibial; articular surface; and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD); e.g.; avascular necrosis; osteoarthritis; and inflammatory degenerative joint disease (IJD); e.g.; rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain; deformity; or dysfunction persists; and revision of previously failed knee arthroplasty. | The firm has 16 reports of patella peg shear out of 109;386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene; Durasul; patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used |
Zimmer Inc. | Jan-25-2012 | Natural-Knee II Durasul All-Poly Patella; Size 0; 7mm – Natural-Knee II Durasul All-Poly Patella; Size 0; 7mmThe Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral; tibial; articular surface; and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD); e.g.; avascular necrosis; osteoarthritis; and inflammatory degenerative joint disease (IJD); e.g.; rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain; deformity; or dysfunction persists; and revision of previously failed knee arthroplasty. | The firm has 16 reports of patella peg shear out of 109;386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene; Durasul; patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used |
Zimmer Inc. | Jan-25-2012 | Natural-Knee II Durasul All-Poly Patella; Size 3; 10mm – Natural-Knee II Durasul All-Poly Patella; Size 3; 10mmThe Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral; tibial; articular surface; and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD); e.g.; avascular necrosis; osteoarthritis; and inflammatory degenerative joint disease (IJD); e.g.; rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain; deformity; or dysfunction persists; and revision of previously failed knee arthroplasty. | The firm has 16 reports of patella peg shear out of 109;386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene; Durasul; patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used |
Lin-Zhi International Inc | Jan-25-2012 | Multi-Analyte Urine DAU Intermediate Calibrator – Multi-Analyte Urine DAU Calibrator (15 mL);Multi-Analyte;Intermediate Calibrator;for in-vitro diagnostic use only.Contains 300 ng/mL benzoylecgonine; 750 ng/mL d-methamphetamine; 4000 ng/m: morphine; 50 phencyclidine; 500 ng/m: oxazepam; 500 ng/mL secobarbital; 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive.Drug abuse testingLin-Zhi International; Inc.’670 Almanor Ave.Sunnyvale; CA 94085. | Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators. |
Lin-Zhi International Inc | Jan-25-2012 | Multi-Analyte Urine DAU Cutoff Calibrator – Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box)For in vitro diagnostic use only.Lin-Zhi International; Inc..670 Almanor Ave.Sunnyvale; CA 94085intended use: Drug abuse detection. | Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings. |
ConMed Corporation | Jan-25-2012 | R2 Adult R2 Non-Radiolucent Multifunction Electrodes – R2 Adult R2 Non-Radiolucent Multifunction Electrodes; Catalog/REF No. 3200-1715; NON-STERILE; MADE IN USA; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13507This device; when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device; when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile; disposable device. | The specific lot was assembled without the rivet cover. |
Siemens Medical Solutions USA; Inc | Jan-25-2012 | Siemens AXIOM Aristos FX Plus – Siemens AXIOM Aristos FX Plus solid state x-ray imager.Image-intensified fluoroscopic x-ray system. | Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type. |
Biomet Microfixation; Inc. | Jan-24-2012 | SternaLock Blu Implant Tray – The SternaLock Blu Implant Tray includes plates; screws; screw measuring device; and blades. The SternaLock Blu Implant Tray would have been found within the following outer containers:Silver Instrument Tray; with a White rack; and there is no Power Driver warning. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville; FL 32218 USA www.biometmicrofixation.com***#73-1301***STERNALOCK IMPLANT TRAY***256X 125.5 MM (10.080 x 4.940 ") (LXW)***Polypropylene; Aluminum; Stainless Steel***"A 3" tall container; with blue rubber handles; and a Power Driver warning on the container lid. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville; FL 32218 USA www.biometmicrofixation.com***#73-1302***STERNALOCK BLU IMPLANT TRAY SEMIMODULAR***256X 125.5 MM (10.080 x 4.940 ") (LXW)Polypropylene; Aluminum; Stainless Steel***"A 5" tall container; with a wide metal latch to secure the lid; and there is no Power Driver warning. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville; FL 32218 USA www.biometmicrofixation.com***#73-1300***STERNALOCK BLU IMPLANT SEMI MODULAR TRAY***228.6X 128.8MM (9.00 x 5.07 ") (LXW)Polypropylene; Aluminum; Radel***".The Biomet Microfixation SternaLock Blu System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. There SternaLock instrument tray has been designed specifically to store the implants for this system. | Biomet Microfixation; Inc.; Jacksonville; FL recalled their SternaLock Blu Implant Tray on 11/23/11; model numbers 73-1300 through 73-1302 due to the possibility of an inaccurate reading on the Screw Measuring Area. If used incorrectly; the screw measuring area inside the SternaLock Blu Implant Tray; could lead to the improper selection of a screw 2mm longer than needed. |
Lin-Zhi International Inc | Jan-24-2012 | Barbiturate Enzyme Immunoassay – Barbiturate Enzyme Immunoassay; R1Antibody/Substrate Reagent (5000 tests and 500 tests);Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody; glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD); stabilizers; and with sodium azide as preservative.and Barbiturate Enzyme Immunoassay R2;Enzyme Conjugate Reagent (5000 tests and 500 test packaging);Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative.For in-vitro diagnostic use only.Lin-Zhi International Inc.670 Almanor Ave.;Sunnyvale; CA 94085Product Usage: Drug testing | Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned. |
Philips Medical Systems (Cleveland) Inc | Jan-24-2012 | Brilliance 64; Brilliance Big Bore; Brilliance iCT; Brilliance iCT SP; Ingenuity CT – Computed Tomography X-Ray Systems (Brilliance 64; Model Number: 728231; Brilliance Big Bore; Model Number: 728243; Brilliance iCT; Model Number: 728306; Brilliance iCT SP; Model Number: 728311; and Ingenuity CT; Model Number: 728326); Mfr. by Philips Medical Systems; Cleveland; OH. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. | The Common Image Reconstruction System (CIRS) on the affected Brilliance Systems encounters an error and requires reboot of the system. The unit failed to initialize axial scan due to timeout that occurred waiting for "READY" state |
Terumo Cardiovascular Systems Corporation | Jan-24-2012 | The Terumo Advanced Perfusion System 1 – Roller Pump; 6 Inch DiameterThe Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. | Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and the 6" roller pumps for the Terumo Advanced Perfusion System 1. |
Terumo Cardiovascular Systems Corporation | Jan-24-2012 | The Terumo Advanced Perfusion System 1 – Roller Pump; 4 Inch DiameterThe Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. | Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and the 6" roller pumps for the Terumo Advanced Perfusion System 1. |
Lin-Zhi International Inc | Jan-23-2012 | Multi-Analyte Urine DAU Control (15 mL); – Multi-Analyte Urine DAU Control (15 mL);Level 2; For in-vitro diagnostic use only.Lin-Zhi International; Inc.670 Almanor Ave.Sunnyvale; CA 94085Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the qualititative and semi-quantitative calibration of Amphetamines Enzyme; Opiate Enzyme; Phencyclidine Enzyme; Cocaine Metabolite Enzyme; Benzodiazepine Enzyme; Barbiturate Enzyme; Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers. | Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Level Calibrators. |
GE Healthcare; LLC | Jan-21-2012 | GE LOGIQ P6 Ultrasound System – GE LOGIQ P6 Ultrasound System.The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; Small Organ (breast; testes; thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and intraoperative (abdominal; thoracic; vascular and neurological). | GE Healthcare has recently become aware of a safety issue associated with the Probe of your LOGIC P6 system that may impact patient safety. GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators. |
Mallinckrodt Inc | Jan-20-2012 | Illumena 150mL Linden Luer Syringe (p/n 900103) & Illumena 150mL Regular Luer Syringe (p/n 900101) – Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101); Made in Mexico; Liebel-Flarsheim Company; Cincinnati; OHThe Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures. | Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw; product 900103; contained the Illumena 150mL Syringe with Handi-Fil Straw; product 900101. |
Biomet Microfixation; Inc. | Jan-20-2012 | 45mm Left Standard Mandible – The 45mm Left Standard Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint.The component is labeled in part: "REF: 24-6546***TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT***QTY 00001***45MM / 7 HOLE CO-CR-MO; TI-6AL-4V ALLOY***BIOMET MICROFIXATION 1520 Tradeport Drive Jacksonville; FL 32218 USA www.biometmicrofixation.com***Product Usage: The Total Temporomandibular Joint (TMJ) Replacement System is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ Replacement System is a two-component system comprised of mandibular condyle and glenoid fossa components. Both components are available in multiple sizes as right and left side specific designs and are attached to bone by screws. Mandibular (Condylar) Prosthesis- The prosthesis is designed to replace the articular surface of the mandibular condyle. The mandibular prosthesis is offered in 3 different sizes: 45mm; 50mm; and 55mm; designated left and right. The mandibular prosthesis is offered in 3 styles:Standard; Offset; and Narrow; to fit a diverse range of mandibular sizes and shapes. The mandibular prosthesis is made of Cobalt Chromium Alloy. The under-surface of the prosthesis is coated with titanium plasma spray for increased bony integration to the mandibular prosthesis. | Biomet Microfixation; Inc.; Jacksonville; FL recalled Part # 24-6546; 45mm Left Standard Mandible and Part # 24-6646; 45mm Left Standard Offset Mandible due to a lot of 24-6246 being etched & labeled as 24-6646 and the reverse; a lot of 24-6646 being etched and labeled as 24-6546. |
Biomet Microfixation; Inc. | Jan-20-2012 | 45mm Left Standard Offset Mandible – The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint.The component is labeled in part: "REF: 24-6646***TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT***QTY 00001***45MM / 7 HOLE CO-CR-MO; TI-6AL-4V ALLOY***BIOMET MICROFIXATION 1520 Tradeport Drive Jacksonville; FL 32218 USA www.biometmicrofixation.com***Product Recall: The Total Temporomandibular Joint (TMJ) Replacement System is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ Replacement System is a two-component system comprised of mandibular condyle and glenoid fossa components. Both components are available in multiple sizes as right and left side specific designs and are attached to bone by screws. Mandibular (Condylar) Prosthesis- The prosthesis is designed to replace the articular surface of the mandibular condyle. The mandibular prosthesis is offered in 3 different sizes: 45mm; 50mm; and 55mm; designated left and right. The mandibular prosthesis is offered in 3 styles:Standard; Offset; and Narrow; to fit a diverse range of mandibular sizes and shapes. The mandibular prosthesis is made of Cobalt Chromium Alloy. The under-surface of the prosthesis is coated with titanium plasma spray for increased bony integration to the mandibular prosthesis. | Biomet Microfixation; Inc.; Jacksonville; FL recalled Part # 24-6546; 45mm Left Standard Mandible and Part # 24-6646; 45mm Left Standard Offset Mandible due to a lot of 24-6246 being etched & labeled as 24-6646 and the reverse; a lot of 24-6646 being etched and labeled as 24-6546. |
Siemens Medical Solutions USA; Inc | Jan-20-2012 | syngo.plaza VA20A; model number 10592457 – Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS; model number 10592457. | The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database are deleted and sent to NULL. This can cause incorrect merging with patients that already had a NULL Patient ID. |
Pentax Medical Company | Jan-20-2012 | Pentax Video Naso Pharyngo Laryngo Scope – EE- Series Video Naso Pharyngo Laryngo Scope; VNL-1570STK.Intended to provide optical visualization (via a video monitor) of the Upper Airway. | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. |
Pentax Medical Company | Jan-20-2012 | Pentax Video Esophagoscopes – EE- Series Video Esophagoscopes; EE-1580K.Intended to provide optical visualization of (via a video monitor) and therapeutic access to; the Upper Gastrointestinal Track. | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. |
Olympus America Inc. | Jan-20-2012 | Olympus Endoscopic Electrosurgical Unit working elements – Olympus Endoscopic Electrosurgical Unit working elements; model numbers WA22366A; and WA22367A.Working element for cutting; coagulation; and vaporization in conductive irrigation fluid or conductive distension medium in the Saline mode. | Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements |
Olympus America Inc. | Jan-20-2012 | Olympus Endoscopic Electrosurgical Unit working elements – Olympus Endoscopic Electrosurgical Unit working elements; model numbers WA22066A and WA22067A.Working element for endoscopic diagnosis and treatment in urological and gynecological applications. | Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements |
Fresenius Medical Care Holdings; Inc. | Jan-20-2012 | Fresenius Optiflux F250NRe Hemodialyzer – Fresenius Optiflux F250NRe Hemodialyzer; ; intended for single use in acute and chronic hemodialysisCatalog No. 0500325EThe Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. | Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak |
Pentax Medical Company | Jan-20-2012 | Pentax Video Bronchoscopes – EB- Series Video Bronchoscopes; EB-1570K & EB-1970K.Intended to provide optical visualization of (via a video monitor); and therapeutic access to; the Pulmonary Tract. | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. |
Gulf Medical Fiberoptics; Inc. | Jan-20-2012 | Surgical Headlight – Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR; FLORIDA U.S.A.* Model Numbers: GMF-H001; GMF-H100; GMF-H101; GMF-H102; GMF-H103; GMF-H104; GMF-H105; and GMF-H106. The Surgical Headlight is a passive luminaire. It is illuminated by a source of light by way of the fiber optics and provides supplemental lighting for medical and surgical procedures. | Gulf Medical Fiberoptics; Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight ; headgear and fiber cable with 70% isopropyl alcohol had not been validated. |
Hospira Inc. | Jan-19-2012 | Hospira Blood Set; with 200 Micron Filter – Hospira Blood Set; with 200 Micron Filter; 80 Inch; Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica; Hospira; Inc.; Lake Forest; IL 60045 USA; list 14203-28.Intended use: for the administration of blood products. | Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. This could cause the piercing pin to slip out of the administration container. |
Mallinckrodt Inc | Jan-19-2012 | Handi-Fil Disposable Syringe Fill Tube – Handi-Fil Disposable Syringe Fill Tube P/N 302050; Plastic & Tyvec pouch; Mallinckrodt; Inc.; Libel-Flarsheim; Cincinnati; OH Made in Mexico.The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube; approximately 10 inches in length; with a "J" shaped curve the projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe. | The firm received complaints from their customers stating that they found open seals on two of their sterilized products. |
Sechrist Industries Inc | Jan-19-2012 | Sechrist Hyperbaric Chamber Gurney. – Sechrist Hyperbaric Chamber Gurney.The Sechrist Hyperbaric Chamber Gurney is an accessory device to the Sechrist Monoplace Hyperbaric Chambers. It is intended solely for the loading and unloading of patients into Sechrist Monoplace Hyperbaric Chambers. It is not intended for general hospital patient transport and is sold only to be used in conjunction with Sechrist Monoplace Hyperbaric Chambers. | Stryker Medical has received complaints from customers that indicate a bushing in the braking system may fracture; which could result in the brake/steer pedal seizing. If the pedal seizes; the braking system may become inoperable or steering around corners may come more difficult. While no injuries have been associated with these reported events nor has there been reported failure events resulting |
Navilyst Medical; Inc | Jan-19-2012 | NAMIC Convienience Kit – NAMIC" Convenience Kit — Legal Manufacturer Navilyst Medical; Inc; 26 Forest St; Marlborough; MA 01752 USA — Made in USA: 10 Glen Falls Technical Park; Glen Falls; NY 12801 USA — each unit label contains the customer name under the name of the product; and each catalog number is specific to the customer.Product usage: For use in fluid management and/or invasive pressure monitoring systems | Navilyst Medical has received reports of damaged manifolds contained in certain NAMIC Convenience Kits which may result in air injection during certain procedures. |
Philips Medical Systems (Cleveland) Inc | Jan-18-2012 | Gemini TF 16 and Gemini TF 64 PET/CT Systems Software Versions 3.5.1 and 3.5.1.1 – GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1); Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1); Model #882471 Philips Medical Systems; Highland Heights; OHThe device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. | Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and; in some cases; raw data being deleted immediately after scan acquisition but before images are reconstructed. |
Stryker Howmedica Osteonics Corp. | Jan-18-2012 | Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instr – Brand Name: Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical InstrumentBrand Name: Specialty Straight Command Common Name: Handle Classification Name: Orthopedics Manual Surgical InstrumentBrand Name: Custom Straight AccoladeCommon Name: HandleClassification Name: Orthopedics Manual Surgical InstrumentBrand Name: Custom Accolade Broach HandleCommon Name: HandleClassification Name: Orthopedics Manual Surgical InstrumentBrand Name: Custom Accolade Broach HandleCommon Name: HandleClassification Name: Orthopedics Manual Surgical InstrumentBrand Name: Specialty Locking Accolade Straight Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical InstrumentBrand Name: Specialty Woodpecker Adapted Accolade BroachHandleCommon Name: HandleClassification Name: Orthopedics Manual Surgical InstrumentStryker Orthopaedics; 325 Corporate Drive; Mahwah; NJ 07430The Handles are instruments that attach to the femoral rasps or broaches to prepare the Femoral Canal in total hip replacement procedures. The rasps have a geometry similar to the final size and shape of the implant. The straight design allows the rasp handle to be used in standard or minimally invasive approaches because it minimizes the contact with adjacent soft tissue. The Handle is impacted with a slotted mallet on the top and on the bottom portions of the striking plate; to achieve rasp insertion and extraction respectively. The handles share the same geometry in the region that is of interest in this matter. | Stryker Orthopaedics has become ware that there is the potential for the above referenced instruments to fracture in two pieces along the width of the body under the striking plate. |
Medtronic Inc. Cardiac Rhythm Disease Management | Jan-18-2012 | Medtronic; DLP; DLP Right Angle Single Stage Venous Cannulae – Medtronic; DLP; DLP Right Angle Single Stage Venous Cannulae. Rx Only; Sterile EO; Nonpyrogenic. Model #’s67512; 67514; 67516; 67518; 67520; 67522; 67524; 67526; 67528; 67530; 67532; 67534; 67636.67638; 67640; 67536;67540.These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p |
Medtronic Inc. Cardiac Rhythm Disease Management | Jan-18-2012 | Medtronic; DLP; DLP Malleable Single Stage Venous Cannulae – Medtronic; DLP; DLP Malleable Single Stage Venous Cannulae.Rx Only; Sterilized Using Ethylene Oxide; Nonpyrogenic. Model #’s68112; 68114; 68116; 68118; 68120; 68122; 68124; 68126; 68128; 68130; 68132; 68134; 68136; 68138; 68140.These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p |
Medtronic Inc. Cardiac Rhythm Disease Management | Jan-18-2012 | Medtronic; Single Stage Venous Cannula – Medtronic; Single Stage Venous Cannula; Carmeda Bio-Active Surface Venous Cannula; Sterilized Using Ethylene Oxide; Rx Only; Nonpyrogenic. Model # ‘sCB66112; CB66114; CB66116; CB66118; CB66120; CB66122; CB66124; CB66128; CB66130; CB66132; CB66134; CB66136; CB66140; CB66236; CB66240; CB67312; CB67314; CB67316; CB67318; CB67320; CB67512; CB67514; CB67516; CB67518; CB67520; CB67522; CB67524; CB67528; CB67530; CB67532; CB67534; CB67536; CB67540; CB67636; CB67640; CB68112; CB68114; CB68116; CB68118; CB68120; CB68122; CB68124; CB68126; CB68128; CB68130; CB68132; CB68134; CB68136; CB68138; CB68140; CB69312; CB69316; CB69320;CB69322; CB69324; CB69328; CB69331; CB69428.These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p |
Medtronic Inc. Cardiac Rhythm Disease Management | Jan-18-2012 | Medtronic Cardio-Kit – Custom Packs/Mexico; Medtronic Cardio-Kit; Sterilized Using Ethylene Oxide; Nonpyrogenic; Rx Only. Model #DLP6N48R3 & DLP6N48R4. Medtronic Intersept Custom Tubing Pack with Trillium Biosurface; Sterilized Using Ethylene Oxide; ; Model # TL4F71R1.These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p |
Medtronic Inc. Cardiac Rhythm Disease Management | Jan-18-2012 | Medtronic Venous Cannula – Custom Packs/ Kerkrade. Contain Medtronic Venous Cannula; Sterile EO. Model #’sC330201C; C330201D; C330201E; C330206B; C342603A; C350106A; C390101D; C390203D; C390406C; C390409B; C390601C; C390601D; C390702A; C390802A; C390903A; C391001B; C391102F; C391104F; C391203A; C391203B; C392502A; C392503A; C410201D; C410407A; C410407B; C431601A; C391104B; C391104D; C390601E; C350103B; C490901B; S342603B.These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p |
Medtronic Inc. Cardiac Rhythm Disease Management | Jan-18-2012 | Medtronic DLP; DLP Single Stage Venous Cannulae – Medtronic DLP; DLP Single Stage Venous Cannulae. Rx Only; Sterile EO; Nonpyrogenic. Model #’s66112; 66114; 66116; 66118; 66120; 66122; 66124; 66126; 66128; 66130; 66132; 66134; 66236; 66238; 66240; 66136; 66140.These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p |
Medtronic Inc. Cardiac Rhythm Disease Management | Jan-18-2012 | Medtronic DLP; DLP Single Stage Venous Cannula w/Right Angle Metal Tip. – Medtronic DLP; DLP Single Stage Venous Cannula w/Right Angle Metal Tip. Rx Only; Sterile EO; Nonpyrogenic. Model number #’s : 67312; 67314; 67316; 67318; 67320; 69312; 69314; 69316; 69318; 68320; 69322; 69324; 69328; 69331; 69424; 69428; 69431; 69528; 69531.These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p |
Medtronic Inc. Cardiac Rhythm Disease Management | Jan-18-2012 | Medtronic; DLP; DLP Malleable Single Stage Venous Cannulae – Medtronic; DLP; DLP Malleable Single Stage Venous CannulaeRx Only; Sterilized Using Ethylene Oxide; Nonpyrogenic. Model # 91037.These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p |
Smiths Medical ASD; Inc. | Jan-17-2012 | CADD High Volume Administration Set – CADD High Volume Administration Set; REF 21-7081V-01; Sterile EO; Rx only; Made in Mexico; Smith Medical ASD; Inc.; 1265 Grey Fox Road; St Paul; Minnesota 55112.Designed for use with CADD pumps to allow fluid delivery from an IV bag. | Smith Medical has become aware of a small number of customer reports regarding occlusions/high pressure alarms with the use of one lot of CADD High Volume Administration Sets. |
Spacelabs Healthcare; Llc | Jan-17-2012 | Spacelabs Medical Ultraview SL Command Module; Model 91496 – Spacelabs Medical Ultraview SL Command Module; Model 91496.The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire; monitor; and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection; respiration; invasive and noninvasive blood pressure; temperature; oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display; recording; editing and analysis. | One Spacelabs Medical Ultraview SL Command Module; Model 91496; was removed from customer due to software error. |
Philips Medical Systems (Cleveland) Inc | Jan-17-2012 | Ingenuity CT system – Ingenuity CT (Computed Tomography) System; 510 (k) #K033326; Model #728326; Serial Numbers: 300003; 300004; and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2.Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64; Brilliance Big Bore; and Ingenuity CT systems; equipped with software version 3.5 Beta 2. The non-conformances are due to software errors identified in these device systems. |
Philips Medical Systems (Cleveland) Inc | Jan-17-2012 | Brilliance Big Bore CT system – Brilliance Big Bore CT (Computed Tomography) System; 510 (k) #K033357; Model #728243; Serial Numbers: 7006; 7154; and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2.Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Software errors. A number of non-conformances were logged in during in-house testing and external validation testing of Brilliance 64; Brilliance Big Bore; and Ingenuity CT systems; equipped with software version 3.5 Beta 2. The non-conformances are due to software errors identified in these device systems. |
Philips Medical Systems (Cleveland) Inc | Jan-17-2012 | Brilliance 64 CT system – Brilliance 64 CT (Computed Tomography) System; 510 (k) #K033326; Model #728231; Serial Numbers: 4003; 9875; and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2.Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Software errors. A number of non-conformances were logged in during in-house testing and external validation testing of Brilliance 64; Brilliance Big Bore; and Ingenuity CT systems; equipped with software version 3.5 Beta 2. The non-conformances are due to software errors identified in these device systems. |
Invacare Corporation | Jan-17-2012 | LEO Scooter – Leo 3-Wheel Scooter and Leo Scooter; Distributed By:Invacare Corporation; 1200 Taylor Street; Elyria; OH 44035Intended to provide transportation for a disabled or elderly person. | Invacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing; and this has the potential to result in a consumer falling causing death or serious injury. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – PRIMUS HI; Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron 77; Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron M 7400/7440 (MXE); Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron 67; Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron M 6700 (MX); Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron M 6300 (MX); Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron M 6730/6740; Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron MD (MD; MDX); Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron KD; Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron ME; Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron KD2; Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron M2 6300;Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron M2 6740;Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron MD-2;Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron KDS-2;Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron KD-2;Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron KDS-2;Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Microgenics Corp | Jan-17-2012 | Tobramycin Calibrators – Tobramycin Calibrators; REF 7F93-01;Microgenics Corporation; 46360 Fremont Blvd Fremont; CA 94538;Distributed by Abbott Diagnostics; 100 Abbott Park Road; Abbott Park; Illinois 60064..Tobramycin is a commonly used antibiotic to treat bacterial infections; in particular gram negative infections. | Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron M2/PRIMUS Mid; Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Medical Solutions USA; Inc | Jan-17-2012 | MEVATRON – Mevatron K2; Siemens HealthcareConcord; CA 94520Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
Siemens Healthcare Diagnostics; Inc. | Jan-15-2012 | Dimension(R) Creatinine Flex(R) Reagent Cartridges – Dimension(R) Creatinine Flex(R) Reagent Cartridges.The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum; plasma; and urine on the Dimension Vista System. | Siemens has confirmed the potential for falsely elevated creatinine results with CREA FLex(R) reagent cartridge lots GA2196; GA2203; DC2221; DB2221; GA2229 and FA2237 when processing tests from a well that has been punctured. |
Sorin Group USA; Inc. | Jan-14-2012 | Apex – Apex Oxygenator; Sterile EO; Distributed in U.S. by: Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | Apex SMART PHisio – Apex SMART PHisio Oxygenator extracorporeal membrane; Sterile EO; Distributed in U.S. by: Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | Apex Phisio – Apex Phisio Oxygenator extracorporeal membrane; Sterile EO; Distributed in U.S. by: Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | Apex HP – Apex HP Oxygenator extracorporeal membrane; Sterile EO; Distributed in U.S. by: Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | Apex HP PHisio – Apex HP PHisio Oxygenator extracorporeal membrane; Sterile EO; Distributed in U.S. by: Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | Sorin Group – PTS Heart/Lung Perfusion Pack Labeling Sterile EO; Product is manufactured by Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004 (utilizing oxygenators manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.)Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | Avant – D 903 Avant Oxygenator extracorporeal membrane; Sterile EO; Distributed in U.S. by: Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | EOS – D 905 EOS Oxygenator extracorporeal membrane; Sterile EO; Distributed in U.S. by: Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | PRIMO2X – PRIMO2X Oxygenator extracorporeal membrane; Sterile EO; Distributed in U.S. by: Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | Synergy – SYNERGY Perfusion Tubing Systems US Denver PHISIO; Sorin Group USA; Tubing set heart-lung bypass; Sterile EO; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | Sorin Synthesis – Synthesis PHisio Oxygenator extracorporeal membrane; Sterile EO; Distributed in U.S. by: Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Sorin Group USA; Inc. | Jan-14-2012 | Apex HP PHisio SMART – Apex HP PHisio SMART Oxygenator extracorporeal membrane; Sterile EO; Distributed in U.S. by: Sorin Group USA; Inc; 14401 W. 65th Way; Arvada; CO 80004; manufactured by: Sorin Group Italia; Via Statale 12 Nord; 86; 41037 Mirandola (MO) Italy.Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours. | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. |
Baxter Healthcare Corp. | Jan-13-2012 | Colleague 3 Volumetric Infusion Pump – Baxter Colleague 3 Triple Channel Volumetric Infusion Pump. Baxter Healthcare Corporation; Medication Delivery Division; Deerfield; IL 60015. Product Code: 2M8153. Product Usage: Intended for use in a wide variety of patient environments for adult; pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration; such as intravenous (IV); intra-arterial (IA); subcutaneous; epidural or irrigation of fluid spaces applications. | Baxter’s Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system. |
Baxter Healthcare Corp. | Jan-13-2012 | Colleague CX Volumetric Infusion Pump – Baxter Colleague CX Infusion Pump; Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation; Medication Delivery Division; Deerfield; IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult; pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration; such as intravenous (IV); intra-arterial (IA); subcutaneous; epidural or irrigation of fluid spaces applications. | Baxter’s Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system. |
Del Mar Reynolds Medical; Ltd. | Jan-13-2012 | Spacelabs Healthcare CardioExpress SL6 ECG cable – Affected device is Model 98400-SL6-AHA; CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However; the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only. | CardioExpress SL6 ECG cable provided with the electrocardiograph is mislabeled. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). |
Linet Americas Inc | Jan-13-2012 | Linet – Linet Remote Handset for model Multicare; Eleganza 3 and Eleganza Smart; hospital bed. Product Usage:Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care. | The premature failure of the Remote Handset buttons may result in unintended movement of the bed. |
Angiodynamics Worldwide Headquarters | Jan-13-2012 | VenaCureEVLT – VenaCureEVLT Perforator Vein Ablation Kit; CATALOG #: EVLT/PVAK; STERILE — Manufactured for: AngioDynamics Inc. 603 Queensbury; NY 12804 USA; AngioDynamics UK Limited; Building 2000; Beach Drive; IQ Cambridge; Waterbeach; Cambridge; CB259TE; United Kingdom — COMMON/USUAL NAME: Laser Surgical Instrument; CLASSIFICATION NAME: Powered Laser Surgical Instrument; DEVICE LISTING # D053485. — Product Usage: The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity. | The product was labeled with a specific indication for the treatment of perforator veins and this specific indication had not received FDA clearance prior to the product being marketed in the US. |
Varian Medical Systems; Inc. Oncology Systems | Jan-13-2012 | Varian brand Eclipse Treatment Planning System – Varian brand Eclipse Treatment Planning System; 7.3; 8.0; 8.1; 8.2; 8.6; 8.9; 10.0; Model Number: H48; Reference/FSCA Identifier: CP-07007; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon; electron and proton beams; as well as for internal irradiation (brachytherapy) treatments. In addition; the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye. | An anomaly has been identified with the Eclipse Treatment Planning System when planning for the Siemens Multileaf Collimator (MLC) where a virtual jaw can be positioned inside the MLC aperture and then used as the beam limiting device for the dose calculation. This will result in an incorrect dose distribution within Eclipse. |
CareFusion 209 Inc. | Jan-13-2012 | NicVue Software version 2.9.2 and 3.0.1. – NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review to archive. The NicVue Software includes the following features and intended uses: Launch Applications; Enter patient information; Import/Export patient information from the Hospital Information System; Move data files; Archive data files on DVD or CDROM. | Under certain work flow processes; when selecting a new patient name in NicVue; the associated exams list may not properly refresh; and may continue to display the previous patient’s exams. |
Olympus America Inc. | Jan-13-2012 | Olympus Electrosurgical Unit (ESG-100) – Olympus Electrosurgical Unit.The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy. | Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100. |
Ortho Development Corporation | Jan-13-2012 | U-Joint Hex Head Driver – U-Joint Hex Head Driver 3.5mm; Part Number 228-0016; for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit.The Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented; biological fixation. The Hex Head Drive is used to place the screw that affixes the acetabular cup to the hip acetabulum. | Tip of hex-head screwdriver may break off during use in hip replacement procedure. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – Cranial Access Kit Ref HITHSP04 Integra NeuroSciences Plainsboro; NJ 08536 Sterile and non-sterile contents; Single use device; Do not resterilize; Prep and Closure Kit Contents Sterile & Non-Sterile; (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO; Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro; NJ 08536 Sterile and non-sterile contents; Single use device; Do not resterilize; Prep and Closure Kit Contents Sterile & Non-Sterile; (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO; Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – Cranial Access Kit Ref SP0153 Integra NeuroSciences Plainsboro; NJ 08536 Contents Sterile and non-sterile; Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO; Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – 1104LC Combo Kit including 1 Camino ICP Monitoring Catheter; 1 Cranial Kit w/Cam Chuck. Integra NeuroSciences; Integra LifeSciences 3498 West 2400 South; West Valley City; Utah 84119.Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – 31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial pressure & temperature monitoring kit; contains sterile and non-sterile product. Integra NeuroSciences; Integra LifeSciences 3498 West 2400 South; West Valley City; Utah 84119.Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – Cranial Access Kit Ref INSHITH Integra NeuroSciences Plainsboro; NJ 08536 Sterile and non-sterile contents; Single use device; Do not resterilize; Prep and Closure Kit Contents Sterile & Non-Sterile; (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO; Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – 1104HMC Combo Kit including 1 Cranial Kit w/Cam Chuck; 1 Micro Ventricular Bolt ICP Monitoring Kit; 1 CSF Drainage System; contains sterile and non-sterile product. Integra NeuroSciences; Integra LifeSciences 3498 West 2400 South; West Valley City; Utah 84119.Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – 1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck; 1 OLM Intracranial Pressure Monitoring Kit; contains sterile and non-sterile product. Integra NeuroSciences; Integra LifeSciences 3498 West 2400 South; West Valley City; Utah 84119.Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro; NJ 08536 Sterile and non-sterile contents; Single use device; Do not resterilize; Prep and Closure Kit Contents Sterile & Non-Sterile; (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO; Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – 1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access; Drain including (1) Cranial Kit W/Cam. Chuck; (1) Ventricular Bolt ICP Monitoring Kit; (1) CSF Drainage System. Contains Sterile and Non-Sterile Product. Integra Life Sciences 3498 West 2400 South; West Valley City; Utah 84119.Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro; NJ 08536 Sterile and non-sterile contents; Single use device; Do not resterilize; Prep and Closure Kit Contents Sterile & Non-Sterile; (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO; Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Integra LifeSciences Corp. d.b.a. Integra Pain Management | Jan-13-2012 | Integra – 31144 Combo Kit including 1 Cranial Kit w/Cam Chuck; 1 Micro Ventricular Bolt ICP; 1 CSF Drainage System; contains sterile and non-sterile product. Integra NeuroSciences; Integra LifeSciences 3498 West 2400 South; West Valley City; Utah 84119.Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations. | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
Impact Instrumentation; Inc. | Jan-12-2012 | Model 750 24′ MRI Reusable/Disposable Circuit – Model 750 24′ MRI Reusable/Disposable CircuitAccessory for use with Model 750 Portable Ventilator | Model 750 24′ MRI Reusable/Disposable Circuit does not have a 510(k). |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax 15.5F x 32 cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip) — Catalog No. [REF] 10302805 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax 15.5F x 22 cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from Tip) — Catalog No. [REF] 10302802 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax 15.5F x 24 cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip) — Catalog No. [REF] 10302803 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) — Catalog No. [REF] 10302804 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax 15.5F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31cm from Tip) — Catalog No. [REF] 10302806 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip) — Catalog No. [REF] 10302807 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax 55 cm STRAIGHT — 1-15.5F x 55cm DuraMax Hemodialysis Catheter (with Cuff 50cm from Tip); 2- Injection Caps — Catalog No. [REF] 10302909 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 22cm Chronic Hemodialysis VascPak (with Cuff 17cm from Tip) — Catalog No. [REF] 10302817 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 24cm Chronic Hemodialysis VascPak (with Cuff 19cm from Tip) — Catalog No. [REF] 10302818 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 28cm Chronic Hemodialysis VascPak (with Cuff 23cm from Tip) — Catalog No. [REF] 10302819 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 32cm Chronic Hemodialysis VascPak (with Cuff 27cm from Tip) — Catalog No. [REF] 10302820 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 40cm Chronic Hemodialysis VascPak (with Cuff 35cm from Tip) — Catalog No. [REF] 10302822 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 55cm Chronic Hemodialysis VascPak (with Cuff 50cm from Tip) — Catalog No. [REF] 10302824 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax 22 cm STRAIGHT — 1-15.5F x 22cm DuraMax Hemodialysis Catheter (with Cuff 17cm from Tip); 2- Injection Caps — Catalog No. [REF] 10302902 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax 24 cm STRAIGHT — 1-15.5F x 24cm DuraMax Hemodialysis Catheter (with Cuff 19cm from Tip); 2- Injection Caps — Catalog No. [REF] 10302903 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
ConMed Corporation | Jan-12-2012 | R2 Adult Zoll Non-Radiolucent Multifunction Electrodes – R2 Adult Zoll Non-Radiolucent Multifunction Electrodes; Catalog/REF 3111-1721; NON-STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13505.This device; when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device; when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile; disposable device. | The product lot was assembled with an R2 Connector; rather than a Zoll Connector. |
Angiodynamics Worldwide Headquarters | Jan-12-2012 | DuraMax – Angiodynamics DuraMax 15.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from Tip) — Catalog No. [REF] 10302809 — MANUFACTURED IN USA AngioDynamics; Inc.; 603 Queensbury Avenue; Queensbury; NY USA 12804Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
SALTER LABS | Jan-11-2012 | ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery – ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery; Model number 4707 7-7-24.Salter Labs Nasal Cannula (Adult); Salter Stylewith modified nasal prongs.w/7′ O2 line and 7′ CO2 line with male luer lock connector.Salter Labs100 W. Sycamore Road;Arvin; CA 93203 | Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors). |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber; 45 cm; VenaCure NeverTouch FRS 45cm Clear Needle; Catalog No./REF 51403001; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. This is a Special Order.Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber; 65 cm; VenaCure NeverTouch FRS 65cm Clear Needle; Catalog No./REF 51403002; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. This is a Special Order.Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber; 65 cm; VC NT FRS 65cm Clear Non-Echo Needle; Catalog No./REF 51403005; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. This is a Special Order.Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Haag-Streit USA Inc | Jan-11-2012 | Octopus 900 – Octopus 900 Perimeter; EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5); Model Number: Octopus 900; Distributed by: Haag-Streit USA; Inc.; 3535 Kings Mills Rd.; Mason; OH 45040 Product Usage: The OCTOPUS 900 Perimeter is designed for the examination; analysis and documentation of the field of sight; especially the light difference sensitivity and other functions of the human eye. | Currently there is a possibility; at the start of the perimetry examination; for the background illumination of the cupola not to turn on. If no illumination of cupola occurs; data obtained from the examination could provide the doctor with results that would appear to be better than actual. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch – FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber; 65 cm; 65cm NeverTouch FRS .018 Procedure Kit; Catalog No./REF 11403013; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch – FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber; 45 cm; 45cm NeverTouch FRS .018 Procedure Kit; Catalog No./REF 11403012; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch – FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber; 65 cm; NT FRS 65cm Kit w/19Ga Needle; Catalog No./REF 11403006; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch – FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber; 45 cm; NT FRS 45cm Kit w/19Ga Needle; Catalog No./REF 11403005; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch – FRS PROCEDURE KIT Featuring Gold-Tipped Fiber; 90 cm; VC EVLT NeverTouch-FRS 90cm Kit; Catalog No./REF 11403004; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch – FRS .018" System PROCEDURE KIT Featuring Gold-Tipped Fiber; 25 cm; VC EVLT NeverTouch-FRS 0.18 25 cm Kit; Catalog No./REF 11403003; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch – FRS PROCEDURE KIT Featuring Gold-Tipped Fiber; 65 cm; NeverTouch 65cm Kit w/Gripper and RFID T; Catalog No./REF 11403002; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch – FRS PROCEDURE KIT Featuring Gold-Tipped Fiber; 45 cm; NeverTouch 45cm Kit w/Gripper and RFID T; Catalog No./REF 11403001; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber; 65 cm; NeverTouch Kit 65CM Internal Sheath; Catalog No./REF 11402002; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber; 45 cm; NeverTouch Kit 45CM Internal Sheath; Catalog No./REF 11402001; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Oculus Innovative Sciences Inc | Jan-11-2012 | Microcyn Dermatology HydroGel Spray – Microcyn Dermatology HydroGel; Spray ; 4 oz and 1.76 oz.Provided Pain Relief; Relieve Itch; Reduces symptoms of inflammation due to irritation; Provide a protective shield against contamination.Antibiotic-free; steroid-free and biodegradable..Oculus Innovative Sciences .Petaluma; CA 94954.Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation; sore; injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns; excluding wounds such as leg ulcers; pressure ulcers; diabetic ulcers; and for the management of mechanically or surgically debrided wounds. | Unapproved drug claims and those not approved under 510K clearance. |
Oculus Innovative Sciences Inc | Jan-11-2012 | Microcyn Dermatology Spray – Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz.99.999% Reduction In-solution in 30 seconds.MRSA – Staphylococcus aureusVFR – Enterococcus faecalisAcinetobacter baumanniiPseudomonas aeruginosa.Microcyn Dermatology Spray has been evaluated by the USP <51> Antimicrobial Effectiveness Test and in Time Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a Category 1 product.Safe to use around eyes; nose and mouth.Oculus Innovative Sciences .Petaluma; CA 94954.Intended for use by health care professionals in management via debridement of wounds | Unapproved drug claims and those not approved under 510K clearance. |
Oculus Innovative Sciences Inc | Jan-11-2012 | Puracyn OTC Wound & Skin Care Solution – Puracyn OTC;Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert.Kills 99.99% of Staph; MRSA; Strep and other Infectious Germs in 30 seconds in solution.Does not contain Antibiotics; Steroids or Alcohol.-Cleans infected wounds in one step- Safe to use around eyes; nose; m mouth and open wounds- Accelerated healing of minor wounds by keeping the wound clean-Non-toxic and non-irritating.Manufactured by Oculus Innovative Sciences for Innovaycen; Inc.3546 N. Riverside Ave. Rialto; CA 92377Made in USA.Intended for OTC use for the management of skin abrasions; lacerations; minor irritations; cuts; and intact skin. | Unapproved drug claims and those not approved under 510K clearance. |
Oculus Innovative Sciences Inc | Jan-11-2012 | Microcyn Solution – Microcyn Solution with Preservatives (Rx); 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL)Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L); Hypochlorous acid (H0CL) (30 mg/L)-Non Foaming-Does not contain antibiotics- Does not facilitate resistance- No known drug/treatment interactions or contraindications-laboratory proven in solution inactivation of bacteria; viruses; fungi and spores.Performance testing: Microcyn Solution with Preservatives has been evaluated by the USP <51> antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a category 1 product.Oculus Innovative Sciences’Petaluma; CA 94954.Intended to be used by health care professionals in the management in wounds. | Unapproved drug claims and those not approved under 510K clearance. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber; 45 cm; NeverTouch Procedure Kit 45cm; Catalog No./REF 51402007; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. This is a Special Order.Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | VenaCure EVLT – VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber; 65 cm; NeverTouch Procedure Kit 65cm; Catalog No./REF 51402008; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804. This is a Special Order.Product Usage: The AngioDynamics; Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux; for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV); and for the treatment of incompetence and reflux of superficial veins of the lower extremity. | During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec; Inc. 300 Sunport Lane; Suite 500 Orlando; FL 32809 USA***CAT.NO.***SIZE***"SIZE 3-3X0 CAT 04-63-2103; SIZE 3-4X0 CAT 04-632104; SIZE 3-5X0 CAT 04-63-2105; SIZE 3-6X0 CAT 04-63-2106. Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec; Inc. 300 Sunport Lane; Suite 500 Orlando; FL 32809 USA***"SIZE 1 x 10mm CAT 04-33-0041; SIZE 2 x 10mm CAT 04-33-0042; SIZE 3 x 10mm CAT 04-33-0043; SIZE 4 x 10mm CAT 04-33-0044; SIZE 5 x 10mm CAT 04-33-0045; SIZE 6 x 10mm CAT 04-33-0046. Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec; Inc. 300 Sunport Lane; Suite 500 Orlando; FL 32809 USA***"SIZE 1 x 7.5mm CAT 04-33-0031; SIZE 2 x 7.5mm CAT 04-33-0032; SIZE 3 x 7.5mm CAT 04-33-0033; SIZE 4 x 7.5mm CAT 04-33-0034; SIZE 5 x 7.5mm CAT 04-33-0035; SIZE 6 x 7.5mm CAT 04-33-0036. Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec; Inc. 300 Sunport Lane; Suite 500 Orlando; FL 32809 USA***"SIZE 1 x 5mm CAT 04-33-0021; SIZE 2 x 5mm CAT 04-33-0022; SIZE 3 x 5mm CAT 04-33-0023; SIZE 4 x 5mm CAT 04-33-0024; SIZE 5 x 5mm CAT 04-33-0025; SIZE 6 x 5mm CAT 04-33-0026.Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec; Inc. 300 Sunport Lane; Suite 500 Orlando; FL 32809 USA***"SIZE 1 x 2.5mm CAT 04-33-0011; SIZE 2 x 2.5mm CAT 04-33-0012; SIZE 3 x 2.5mm CAT 04-33-0013; SIZE 4 x 2.5mm CAT 04-33-0014; SIZE 5 x 2.5mm CAT 04-33-0015; SIZE 6 x 2.5mm CAT 04-33-0016. Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec; Inc. 300 Sunport Lane; Suite 500 Orlando; FL 32809 USA***"SIZE 1 x 0mm CAT 04-33-0001; SIZE 2 x 0mm CAT 04-33-0002; SIZE 3 x 0mm CAT 04-33-0003; SIZE 4 x 0mm CAT 04-33-0004; SIZE 5 x 0mm CAT 04-33-0005; SIZE 6 x 0mm CAT 04-33-0006. Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec; Inc. 300 Sunport Lane; Suite 500 Orlando; FL 32809 USA***CAT.NO.***SIZE***"SIZE 3-3X2.5 CAT 04-63-2113; SIZE 3-4X2.5 CAT 04-63-2114; SIZE 3-5X2.5 CAT 04-63-2115; SIZE 3-6X2.5 CAT 04-63-2116. Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Siemens Medical Solutions USA; Inc | Jan-11-2012 | Siemens syngo Imaging XS; all versions – syngo Imaging XS; all versionsRadiological image processing system | Unintended behavior when using syngo Imaging XS; all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec; Inc. 20 Valley Street South Orange NJ; 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking; Surrey GU213BA England Tel (0)1483-721404***" Size: 04-33-1032 Modular Tibial Bearing 2 X 7.504-33-1033 Modular Tibial Bearing 3 X 7.504-33-1034 Modular Tibial Bearing 4 X 7.504-33-1035 Modular Tibial Bearing 5 X 7.5 04-33-1036 Modular Tibial Bearing 6 X 7.5.Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec; Inc. 20 Valley Street South Orange NJ; 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking; Surrey GU213BA England Tel (0)1483-721404***" Size:04-33-1022 Modular Tibial Bearing 2 x 504-33-1023 Modular Tibial Bearing 3 X 504-33-1024 Modular Tibial Bearing 4 X 504-33-1025 Modular Tibial Bearing 5 X 504-33-1026 Modular Tibial Bearing 6 X 5.Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec; Inc. 20 Valley Street South Orange NJ; 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking; Surrey GU213BA England Tel (0)1483-721404***" Size: 04-33-1012 Modular Tibial Bearing 2 X 2.504-33-1013 Modular Tibial Bearing 3 X 2.504-33-1014 Modular Tibial Bearing 4 X 2.5 04-33-1015 Modular Tibial Bearing 5 X 2.504-33-1016 Modular Tibial Bearing 6 X 2.5.Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS MODULAR TIBIAL BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec; Inc. 20 Valley Street South Orange NJ; 07079 USA Tel (973)762-6100***Wright Cremascoli Ortho Ltd. Unit 17 Goldworth Park Trading Estate Woking; Surrey GU213BA England Tel (0)1483-721404***" Cat #: 04-33-1002 Modular Tibial Bearing 2 X 0 Cat #: 04-33-1003 Modular Tibial Bearing 3 X 0 Cat #: 04-33-1004 Modular Tibial Bearing 4 X 0 Cat #: 04-33-1005 Modular Tibial Bearing 5 X 0 Cat #: 04-33-1006 Modular Tibial Bearing 6 X 0.Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec; Inc. 300 Sunport Lane; Suite 500 Orlando; FL 32809 USA***CAT.NO.***SIZE***"SIZE 3-3X7.5 CAT 04-63-2133; SIZE 3-4X7.5 CAT 04-63-2134; SIZE 3-5X7.5 CAT 04-63-2135; SIZE 3-6X7.5 CAT 04-63-2136. Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Endotec; Inc. | Jan-11-2012 | Beuchal Pappas Mobile Bearing Knee System – "***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec; Inc. 300 Sunport Lane; Suite 500 Orlando; FL 32809 USA***CAT.NO.***SIZE***"SIZE 3-3X5 CAT 04-63-2123; SIZE 3-4X5 CAT 04-63-2124; SIZE 3-5X5 CAT 04-63-2125; SIZE 3-6X5 CAT 04-63-2126. Tricompartmental Knee Replacement | On 09/21/2011 Endotec; Orlando; FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components. |
Innovatech Medical Resources L.P. | Jan-11-2012 | 3.0 60 Degree wand Part Number A2530-01 – 3.0 60 Degree wand Part Number A2530-01 is an ablation wandIntended for resection; ablation; and coagulation of soft tissue; and hemostasis of blood vessels. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | OPUS Minimagnum Implant Part Number OM-2500 – OPUS Minimagnum Implant Part Number OM-2500 is a bone anchorIntended for rotator cuff repair | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | Lancelot 90 Degree with Cable Part Number ASC4145-01 – Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | OPUS Magnum 2 Plus Implant Product Number OM-1502 – OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchorIntended for rotator cuff repair in the shoulder. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | Turbo Vac 90 with Cable Part Number ASC1335-01 – Turbo Vac 90 with Cable Part Number ASC1335-01 is an ablation wandIndicated for resection; ablation; and coagulation of soft tissue; and hemostasis of blood vessels in arthroscopic and orthopedic proce | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | Saber 30 Part Number A4330-01 – Saber 30 Part Number A4330-01 is an ablation wandIndicated for resection; ablation; and coagulation of soft tissue; and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | 3.5mm 90 Degree Part Number A1335-01 – 3.5mm 90 Degree Part Number A1335-01 is an ablation wandIntended for resection; ablation; and coagulation of soft tissue; and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | 3.0mm 45 Degree bevel Part Number A2430-01 – 3.0mm 45 Degree bevel Part Number A2430-01 is an ablation wandIntended for resection; ablation; and coagulation of soft tissue; and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | CoVac 70 Product Number AS3730-01 – CoVac 70 Product Number AS3730-01 is an ablation wandIntended for resection; ablation; and coagulation of soft tissues and hemostasis of blood vessels in arthroscopic procedures. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | CoVac 50 Product Number AS2530-01 – CoVac 50 Product Number AS2530-01 is an ablation wandIntended for resection; ablation; and coagulation of soft tissue; and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | MultiVac Tristar 50 Product Number AS4630-01 – MultiVac Tristar 50 Product Number AS4630-01 is an ablation wandIntended for resection; ablation; and coagulation of soft tissue; and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | SideWinder Hip Wand Product Number AC2340-01 – SideWinder Hip Wand Product Number AC2340-01 is an ablation wandIntended for resection; ablation; and coagulation of soft tissue; and hemostasis of blood vessels in arthroscopic and orthopedic procedures | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | 3.0mm 45 Degree Beval with cable Product Number AC2430-01 – 3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | 5.0 mm Parafix Part Number 22-5011 – 5.0 mm Parafix Part Number 22-5011 is a suture anchor metalIntended for rotator cuff repair. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | OPUS Magnum 2 Plus Implant Product Number OM-9026 – OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kitsIntended for rotator cuff repair. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | OPUS Magnum 2 Plus Implant Product Number OM-9027 – OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502 Intended for rotator cuff repair | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | OPUS SpeedStitch Product Number OM-8086 – OPUS SpeedStitch Product Number OM-8086 is a suture cartridgeFor use in approximation and/or ligation of soft tissues; including use of allograft tissue for orthopedic surgeries. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | OPUS SmartStitch Product Number OM-8178 – OPUS SmartStitch Product Number OM-8178 is a suture cartridgeFor use in approximation and/or ligation of soft tissues; including use of allograft tissue for orthopedic surgeries. | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | OPUS SmartStitch M-Connector Product Number OM-8007 – OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | OPUS SpeedScrew Implant Product Number OM-6500 – OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchorIntended to be used for fixation of soft tissue to bones | Product is being removed from the field due to an over-label issue. |
Innovatech Medical Resources L.P. | Jan-11-2012 | 90 Degree LoPro with Cable Part Number AC1336-01 – 90 Degree LoPro with Cable Part Number AC1336-01 is an ablation wandIntended for resection; ablation; and coagulation of soft tissue; and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is being removed from the field due to an over-label issue. |
GE Healthcare; LLC | Jan-11-2012 | Definium 8000 – GE Healthcare Definium 8000; Digital Radiographic Systems. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. | GE Healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the Definium 8000 and Discovery XR650 image pasting systems that may impact patient and user safety. The patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. Thi |
St Jude Medical CRMD | Jan-11-2012 | Accent DR – Implantable Pacemaker Accent DR models PM2110 and PM2210St. Jude Medical pacemakers monitor and regulate a patient’s heart rate with pacing therapy. | St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false. |
GE Healthcare; LLC | Jan-11-2012 | Discovery XR650 – GE Healthcare Discovery XR650; Digital Radiographic Systems. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. | GE Healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the Definium 8000 and Discovery XR650 image pasting systems that may impact patient and user safety. The patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. Thi |
St Jude Medical CRMD | Jan-11-2012 | Anthem CRT-P – Anthem CRT-P models PM3110 and PM3210St. Jude Medical pacemakers monitor and regulate a patient’s heart rate with pacing therapy. | St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false. |
Ormco Corporation | Jan-11-2012 | TMA Archwires – TMA Archwires; Part Number 211-1402; Lot Number 10K291; Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment. | The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires; part number 2021007. |
ICU Medical; Inc. | Jan-11-2012 | Orbit and Orbit Micro – Orbit and Orbit MicroSubcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our devices within an outer container. Removal of the wipes will not compromise the sterile barrier of our device and can easily be identified and replaced. | The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group’s alcohol prep pads; alcohol swabs; and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names. The Triad alcohol prep pads have the potential contamination of the bacteria; Bacillus cereus. The Triad Group alcohol prep pads have been copackaged |
ICU Medical; Inc. | Jan-11-2012 | IV Start Kits – IV Start KitsConvenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe. | The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group’s alcohol prep pads; alcohol swabs; and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names. The Triad alcohol prep pads have the potential contamination of the bacteria; Bacillus cereus. The Triad Group alcohol prep pads have been copackaged a |
Philips Medical Systems | Jan-11-2012 | SKYLight Imaging Systems – SKYLight Imaging Systems; Model 882050;Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | During preventative maintenance; a crack was discovered in the lower portion of the old style; non-common arm for the detector assembly; which could result in the detector dropping in an uncontrolled manner. |
Varian Medical Systems; Inc. Oncology Systems | Jan-11-2012 | Portal Vision (Electronic Portal Image Device) R-Arm with 4D Integrated Treatment Console – Portal Vision; R-Arm with 4D Integrated Treatment Console;Varian Medical Systems. Palo Alto; CA.The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment. | An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images. |
Osteotech Inc | Jan-11-2012 | Grafton DBM Flex – Grafton DBM Flex; Unit Size 5×5 cm; 1eaContainer: Foil Pouch with Tyvek pouchFracture repair; bridge bone gaps or fragments; use with strut grafts | Aseptic conditions during the production of these products may have been compromised. |
Osteotech Inc | Jan-11-2012 | Grafton DBM A-Flex – Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea Container: Foil Pouch with Tyvek pouchFracture repair; bridge bone gaps or fragments; use with strut grafts | Aseptic conditions during the production of these products may have been compromised. |
Biomet; Inc. | Jan-11-2012 | Biomet Series A Thin Patella 25mm; three pegs; Part 184780 – Biomet Series A Thin Patella size 25mm; three pegs; Part 184780; Sterile; Biomet Orthopedics; Warsaw; IN 46582 For use with Vanguard; Maxim; Ascent & AGC Knee Systems. Knee joint patellofemorotibial; cemented; polymer /metal/polymer; semi-constrained. Knee joint replacement prosthesis; intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
Biomet; Inc. | Jan-11-2012 | Biomet Series A Standard Patella size 25mm; one peg – 184700 – Biomet Series A Standard Patella size 25mm; one peg; Part 184700; Sterile; Biomet Orthopedics; Warsaw; IN 46582Knee joint patellofemorotibial; cemented; polymer/metal/polymer; semi-constrained. For use with Vanguard; Maxim; Ascent & ACG knee system.Knee joint replacement prosthesis; intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
Biomet; Inc. | Jan-11-2012 | Biomet Series A Standard Patella size 28mm; one peg – 184702 – Biomet Series A Standard Patella size 28mm; one peg – 184702; Biomet Orthopedics; Warsaw; IN 46582 For use with Vanguard; Maxim; Ascent & ACG Knee system. Knee joint patellofemorotibial; cemented; polymer/metal/polymer; semi-constrained. Knee joint replacement prosthesis; intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
Biomet; Inc. | Jan-11-2012 | Biomet Series A Thin Patella size 25mm; one peg – 184720 – Biomet Series A Thin Patella size 25mm; one peg – 184720Sterile; Biomet Orthopedics; Warsaw; IN 46582 For use with Vanguard; Maxim; Ascent & AGC Knee SystemsKnee joint patellofemorotibial; cemented; polymer/metal/polymer; semi-constrained.Knee joint replacement prosthesis; intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
Biomet; Inc. | Jan-11-2012 | Biomet Series A Thin Patella size 25mm; one peg – 184720 – Biomet Series A Thin Patella size 25mm; one peg – 184720; Sterile; Biomet Orthopedics; Warsaw; IN 46582For use with Vanguard; Maxim; Ascent & AGC Knee SystemsKnee joint patellofemorotibial; cemented; polymer/metal/polymer; semi-constrained. Knee joint replacement prosthesis; intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
Teco Diagnostics | Jan-11-2012 | Urine Reagent Strips (URS) 10 Parameters – Urine Reagent Strips (URS) 10 ParametersURS-l0-1OOW510(K) number: K970250Devise Listing number: D072377Each device consists of 100 strips of Urine Reagent Strips 10 parameterspacked with a desiccant pouch inside a gray bottle with Teco DiagnosticsLabel on the bottle and the bottle placed inside a Teco Diagnostics Box.For the semi-quantitative and qualitative detection of Glucose; Bilirubin; Ketone; Specific Gravity; Blood; pH; Protein; Urobilinogen; Nitrite; Leukocytes in urine. | This recall was initiated in response to findings during a FDA inspection of the firm. The firm’s recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134; Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets (Refer to next paragraph). Sampling size submitted for QC testing was insuff |
Biomet; Inc. | Jan-11-2012 | Biomet Series A Standard Patella size 28mm; three pegs – 184762 – Biomet Series A Standard Patella size 28mm; three pegs – 184762; Sterile; Biomet Orthopedics; Warsaw; IN 46582For use with Vanguard; Maxim; Ascent & AGC Knee SystemsKnee joint patellofemorotibial; cemented; polymer/metal/polymer; semi-constrained. Knee joint replacement prosthesis; intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
Biomet; Inc. | Jan-11-2012 | Biomet Series A Thin Patella size 28mm; three pegs – 184782 – Biomet Series A Thin Patella size 28mm; three pegs – 184782;Sterile; Biomet Orthopedics; Warsaw; IN 46582For use with Vanguard; Maxim; Ascent & AGC Knee SystemsKnee joint patellofemorotibial; cemented; polymer/metal/polymer; semi-constrained. Knee joint replacement prosthesis; intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
Biomet; Inc. | Jan-11-2012 | Biomet Series A Thin Patella size 28mm; three pegs – 184782 – Biomet Series A Asymmetrical Patella size 25mm; three pegs – 184790; Sterile; Biomet Orthopedics; Warsaw; IN 46582 For use with Vanguard; Maxim; Ascent & AGC Knee Systems Knee. Joint patellofemorotibial; cemented; polymer/metal/polymer; semi-constrained. Knee joint replacement prosthesis; intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
Biomet; Inc. | Jan-11-2012 | Biomet Series A Asymmetrical Patella size 28mm; three pegs – 184791 – Biomet Series A Asymmetrical Patella size 28mm; three pegs – 184791; Sterile; Biomet Orthopedics; Warsaw; IN 46582 For use with Vanguard; Maxim; Ascent & AGC Knee Systems Knee. Joint patellofemorotibial; cemented; polymer/metal/polymer; semi-constrained. Knee joint replacement prosthesis; intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
Teco Diagnostics | Jan-11-2012 | Urine Reagent Strips (URS) 10 Parameters – Urine Reagent Strips (URS) 10 ParametersURS-l0-1OOW510(K) number: K970250Devise Listing number: D072377Each device consists of 100 strips of Urine Reagent Strips 10 parameterspacked with a desiccant pouch inside a gray bottle with Teco DiagnosticsLabel on the bottle and the bottle placed inside a Teco Diagnostics Box.For the semi-quantitative and qualitative detection of Glucose; Bilirubin; Ketone; Specific Gravity; Blood; pH; Protein; Urobilinogen; Nitrite; Leukocytes in urine. | This recall was initiated in response to findings during a FDA inspection of the firm. The firm’s recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134; Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets (Refer to next paragraph). Sampling size submitted for QC testing was insuff |
Biomet; Inc. | Jan-11-2012 | Biomet Series A Standard Patella size 25mm; three pegs – 184760 – Biomet Series A Standard Patella size 25mm; three pegs – 184760; Sterile; Biomet Orthopedics; Warsaw; IN 46582For use with Vanguard; Maxim; Ascent & AGC Knee SystemsKnee joint patellofemorotibial; cemented; polymer/metal/polymer; semi-constrained. Knee joint replacement prosthesis; intended for patella replacement of the knee joint in conjunction with a femoral and tibial component. | Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system. |
Alere San Diego | Jan-11-2012 | Triage Drugs of Abuse Panel Plus TCA – Triage Drugs of Abuse Panel Plus TCA 25 Test Kit; PN (Model Number) 92000An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in urine. | The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928. |
The Raymond Corporation | Jan-11-2012 | Raymond Corporation Fork-Tip Laser Guide – Raymond Laser alignment guide – Model #1096597/001 Green Laser.Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load. | Raymond shipped a laser alignment guide as an option on its powered industrial trucks from February 2; 2010 through April 21; 2011; but was not aware of its obligation under 21 C.F.R. 1010.2 and 1010.3 to certify and label. |
Teleflex Medical | Jan-11-2012 | Rusch – Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip; 6FR; Catalog numbers: 502501; Teleflex Medical Sdn Bhd; P.O. Box; Industrial Estate; 24600 Kamunting; Perak; Malaysia.Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient. | Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received. |
Philips Medical Systems (Cleveland); Inc. | Jan-11-2012 | Pinnacle3 Radiation Therapy Planning System – Pinnacle3 Radiation Therapy Planning System; software version 9.0.Model # Description453560446041 Pinnacle3 version 9.0 English453560446051 Pinnacle3 version 9.0 Simplified Chinese453560446061 Pinnacle3 version 9.0 Traditional Chinese453560446091 Pinnacle3 version 9.0 Dutch453560446101 Pinnacle3 version 9.0 French453560446111 Pinnacle3 version 9.0 German453560446141 Pinnacle3 version 9.0 Italian453560446161 Pinnacle3 version 9.0 Japanese453560446181 Pinnacle3 version 9.0 Spanish453560446201 Pinnacle3 version 9.0 TurkishIntended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. | Phillips Medical Systems have recently determined that a software (Pinnacle3 Software version 9.0) nonconformance can cause incorrect beam geometry. |
The Raymond Corporation | Jan-11-2012 | Raymond Corporation Fork-Tip Laser Guide – Raymond Laser alignment guide – Model #1096597/002 Red Laser.Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load. | Raymond shipped a laser alignment guide as an option on its powered industrial trucks from February 2; 2010 through April 21; 2011; but was not aware of its obligation under 21 C.F.R. 1010.2 and 1010.3 to certify and label. |
Orthohelix Surgical Designs Inc | Jan-11-2012 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM – MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP; TMT; MFT; MXL; DFX; and EDL plates are indicated for fractures; fusions and osteotomies for small bones in the hand; wrist; foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures; fusions; and osteotomies of the clavicle and small bones in the hand; wrist; foot and ankle. | The firm discovered a testing protocol error; in both dynamic and static cantilever comparative testing; during the initial comparative testing. |
Covidien; PLC | Jan-11-2012 | LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider – LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider; LS1520; Sterile EO; Manufactured for Valleylab a division of Tyco Healthcare Group LP; Boulder; CO 80301; Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC; Building No. 10; 789 Puxing Rd.; Shanghai 201114; P.R. China.Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics; and tissue bundles. | Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching. |
Covidien; PLC | Jan-11-2012 | LigaSure V 5 mm Dolphin Tip Laparoscopic – LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider; LS1500; Sterile EO; Manufactured for Valleylab; a division of Tyco Healthcare Group LP; Boulder; CO. Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC; Building No. 10; 789 Puxing Road; Shanghai 201114; P.R. Chin.; Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics; and tissue bundles. | Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching. |
Navilyst Medical; Inc | Jan-11-2012 | Exodus(TM) Standard Loop Biliary Drainage Catheter with Hydrophilic Coating – Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating; REF/ Catalog No. 10005; UPN/Product No. H965100051; STERILE — Package/Box Units: Box of 5 eaches — Made in USA: 2301 Centennial Blvd. Jeffersonville; IN 47130 — Manufactured for: Navilyst Medical; Inc. 26 Forest Street Marlborough; MA 01752 — The Exodus Drainage Catheter consists of a radiopaquepolyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. | Navilyst Medical; Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated. |
Synthes USA | Jan-11-2012 | SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE – SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE; Part Number SRS-005-FSP; Lot number N001101.Bone void filler. | A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing; Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements. The product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements. |
Baxter Healthcare Corp. | Jan-11-2012 | Colleague CX Infusion Pump – Baxter Colleague CX Infusion Pump; Single Channel Volumetric Infusion Pumps. Product Code: 2M8161. | There was no documentation to show the required tests were performed following the replacement of the battery and battery harness. |
Navilyst Medical; Inc | Jan-11-2012 | Exodus(TM) Standard Loop Biliary Drainage Catheter with Hydrophilic Coating – Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating; REF/Catalog No. 10013; UPN/Product No. H965100131; STERILE — Package/Box Units: Box of 5 eaches — Made in USA: 2301 Centennial Blvd.; Jeffersonville; IN 47130 — Manufactured for: Navilyst Medical; Inc. 26 Forest Street; Marlborough; MA 01752 USA — The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement.Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. | Navilyst Medical; Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated. |
Eyezone | Jan-11-2012 | Neulook – Neulook Deluxe is packaged in a pink soft plastic box with white; black; and rainbow printing that reads;NeuLook COLOR CONTACT LENSES Give yourself a whole new look***LENS CASE INCLUDED HOT RED PWR. 0.00 LOT. BD53***EXP. 2014/08***Contents : Two sterile color contact lenses(62% Polymacon; 38% Water) Immersed in saline and one lens case. Caution : To ensure that your contacts stay comfortable and your Vision stay clear; ask your eye-care professional for product instruction. Made in Korea www.NeuLooklens.com Distributed by EYEZONE***1023 FDA 510K CLEARED***STERILE***B.C 8.6mm DIA. 14.0mm***8 806048 000468.The color contact lens colors are: Black out; vein; night; white cat; red cat devil; blue angelic; white out; and hot red.prescription contact lens | This recall has been initiated because Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded. |
Eyezone | Jan-11-2012 | Neulook – Neulook Fancy FX is packaged in a small glass bottle with a orange; white; and yellow affixed label with black printing that reads; NeuLook COLOR CONTACT LENSES Distributed by EYEZONE Contents : One Lens; 38% water and 62% Polymacon immersed in saline. Caution : To ensure that your contacts stay comfortable and your vision stay clear; ask your eye-care professional for product instruction. ***DIA. 14.0mm B.C 8.6mm***Rxonly STERILE***FDA 510K Cleared Made in Korea***Power : PlaneColor : Blue Angelic The color contact lens colors are: Aqua; blue; blue sapphire; dark gray; dark violet; gray; green; hazel; honey; jade; magic angel; misty blue; misty green; misty hazel; pearl gray; pure hazel; sky blue; sweet gray; turquoise; violet; black out; vein; night; white cat; red cat devil; blue angelic; white out; hot red spider web; psycho; cruller; solid yellow; and blue wheel.prescription contact lens | This recall has been initiated because Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded. |
Philips Healthcare Inc. | Jan-11-2012 | Philips Multi Diagnost Eleva – Philips Multi Diagnost Eleva with Flat Software R5.2.2.Philips MultiDiagnost Eleva system is intended to be Intended used as a multifunctional/Universal system. General RIF; Fluoroscopy; Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system; Skeletal system; Urinary system; Reproductive system; Respiratory system; Circulatory system; and various : Arthrograms; Myelograms ; Facet joint injections ; Discography; Sialography. | Displayed Dose Area Product (DAP) is displayed by a factor 100 too low. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Y-Type Blood/Solution Set – Baxter Interlink System Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter; Length 95" (2.4 m); Injection Site; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the removal of microaggregates from whole blood or red blood cells and transfusion of platelets; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 4C6838Intended use: for the removal of microaggregates from whole blood or red blood cells and transfusion of platelets | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Medtronic Sofamor Danek USA Inc | Jan-11-2012 | MULTI-AXIAL SCREW – CD HORIZON (R) Spinal System; MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD; Size 6.5mm X 40mm; Mat’l TITANIUM ALLOY; REF X1010484; Rx only; Medtronic Sofamor Danek USA; 1800 Pyramid Place; Memphis; TN 38132implantation | One screw may be longer then size etched on the screw. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Continu-Flo Solution Set – Baxter Interlink System Continu-Flo Solution Set; 71" (1.8 m); 2 Injection Sites; Male Luer Lock Adapter; Standard Bore 3-Way Stopcock Manifold; Extension Set; 44" (112 cm); Vol. 6.6 mL; Injection Site; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 1C8369.Intended use: for the administration of drug and solutions to patient’s vascular system through a vascular access device | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Continu-Flo Solution Set – Baxter Interlink System Continu-Flo Solution Set; 69" (1.8 m); 2 Injection Sites; Male Luer Lock Adapter; Standard Bore 4-Way Stopcock with Rotating Male Luer Lock;; Extension Set; 61" (155 cm); Vol. 8.5 mL; 2 Injection Sites; Male Luer Lock Adapter with Retractable Collar; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 1C8371Intended use: for the administration of drug and solutions to patient’s vascular system through a vascular access device | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Extension Set – Baxter Interlink System Extension Set; 20" (51 cm); Vol. 2.9 mL; Injection Site; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 1C8376Intended use: for the administration of sterile I.V. fluids to the patient | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Vented Continu-Flo Solution Set – Baxter Interlink System Vented Continu-Flo Solution Set; 100" (2.5 m); Vol. 2.9 mL; 3 Injection Sites; Male Luer Lock Adapter with Retractable Collar; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 1C8533Intended use: for the administration of sterile I.V. fluids to the patient | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Y-Type Solution Set – Baxter Interlink System Y-Type Solution Set; 78" (2.0 m); 2 Injection Sites; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 1C8581Intended use: for the administration of drug and solutions to patient’s vascular system through a vascular access device | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator – Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator; 89" (2.3 m); 2 Injection Sites; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 1C8621Intended use: for the administration of drug and solutions to patient’s vascular system through a vascular access device | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Extension Set – Baxter Interlink System Extension Set; 13" (32 cm); Check Valve; Injection Site; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 2C6605Intended use: for the administration of drug and solutions to patient’s vascular system through a vascular access device | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System 3-Port Manifold Extension Set – Baxter Interlink System 3-Port Manifold with Check Valves; Vol. 1.0 mL; Large Bore 4-Way Stopcock Extension Set; Vol. 6.2 mL; 41" (104 cm); 2 Injection Sites; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 2C6921Intended use: for the administration of sterile I.V. fluids to the patient | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Continu-Flo Solution Set 3-Port Manifold Extension Set – Baxter Interlink System Continu-Flo Solution Set; length 89" (2.3 m); 2 Injection Sites; Male Luer Lock Adapter; 3-Port Manifold with Check Valves; Vol. 1.0 mL; Large Bore 4-Way Stopcock Extension Set; Vol. 6.2 mL; Length 41" (104 cm); 2 Injection Sites; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 2C6931Intended use: for the administration of sterile I.V. fluids to the patient | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Continu-Flo Solution Set 3-Port Manifold Extension Set – Baxter Interlink System Continu-Flo Solution Set; length 89" (2.3 m); 2 Injection Sites; Male Luer Lock Adapter; 3-Port Manifold with Check Valves; Vol. 1.0 mL; Extension Set; Vol. 5.6 mL; Length 39" (99 cm); 2 Injection Sites; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 2C6951Intended use: for the administration of sterile I.V. fluids to the patient | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Solution Set – Baxter Interlink System Solution Set; 67" (1.7 m); Injection Site; Male Luer Lock Adapter; Standard Bore 4-Way Stopcock Manifold; Extension Set; 43" (109 cm); Vol. 6.5 mL; Injection Site; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 3C0039Intended use: for the administration of drug and solutions to patient’s vascular system through a vascular access device | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Continu-Flo Solution Set – Baxter Interlink System Continu-Flo Solution Set; 71" (1.8 m); 2 Injection Sites; Male Luer Lock Adapter; Standard Bore 4-Way Stopcock Manifold; Standard Bore 4-Way Stopcock with Rotating Male Luer Lock; Extension Set; 39" (99 cm); Vol. 5.8 mL; Injection Site; Male Luer Lock Adapter; Extension Set; 8" (20 cm); Vol. 1.1 mL; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 3C0142Intended use: for the administration of sterile I.V. fluids to the patient | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Baxter Healthcare Corp. | Jan-11-2012 | Baxter Interlink System Straight Type Blood Set – Baxter Interlink System Straight Type Blood Set with 40 and 150 Micron Dual Screen Filter; Length 86" (2.2 m); Injection Site; Male Luer Lock Adapter; an Rx sterile; nonpyrogenic fluid pathway for the removal of microaggregates from whole blood or red blood cells and transfusion of platelets; Baxter Healthcare Corporation; Deerfield; IL 60015 USA; product code 4C6832Intended use: for the removal of microaggregates from whole blood or red blood cells and transfusion of platelets | During production of the IV sets; solvent was inadvertently applied to the locking collar of the male luer connector; which may have damaged the component; preventing proper engagement of the locking collar to secure a connection. |
Medtronic Sofamor Danek USA Inc | Jan-11-2012 | MULTI-AXIAL SCREW – CD HORIZON (R) Spinal System; MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD; Size 6.5mm X 40mm; Mat’l TITANIUM ALLOY; REF X0809439; Rx only; Medtronic Sofamor Danek USA; 1800 Pyramid Place; Memphis; TN 38132implantation | One screw may be longer then size etched on the screw. |
Siemens Healthcare Diagnostics; Inc. | Jan-11-2012 | Dimension Vista(R) Cardiac Troponin I Calibrator – Siemens Healthcare Diagnostics; Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085; in vitro diagnostic | Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients. |
Siemens Healthcare Diagnostics; Inc. | Jan-11-2012 | Dimension(R) Vista(R) V-LYTE(R) – Dimension(R) Vista(R) V-LYTE(R) Standard A (K820)Product Usage: V-LYTE(R) Standard A is for the calibration of NA; K; and CL on the Dimension Vista(R) system | Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IMT sensor. The results can be elevated approximately 10-20% which may cause QC recovery being out of acceptable ranges. Patient Urine sodium results may also b |
Siemens Healthcare Diagnostics; Inc. | Jan-11-2012 | Dimension(R) Vista(R) V-LYTE(R) – Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825)Product Usage: V-LYTE(R) Standard B/Salt Bridge is for the calibration and measurement of NA; K; and CL on the Dimension Vista(R) system | Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IMT sensor. The results can be elevated approximately 10-20% which may cause QC recovery being out of acceptable ranges. Patient Urine sodium results may also b |
Medical Compression Systems | Jan-11-2012 | ActiveCare DVT – ActiveCare DVTMedical Compression SystemsOR Aqiva; ILIntended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis; venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema | This voluntary field action is being undertaken because MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found that an ActiveCare DVT device may work improperly if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product’s User Manual; the ActiveCare DVT |
Teleflex Medical | Jan-11-2012 | DuraHook Neuro Elastic Retractors – Weck; DuraHook (6mm) and (12mm); Neuro Elastic Retractors; 6 per Package; 10 Packages per Sales Units; 10 Sales Units per Shipper; Rx Only; Teleflex Medical; Research Triangle Park; NC 277809.For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. | Teleflex Medical received complaints that the elastic bands are breaking; cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure; loss of the band in the operative field as well as inadvertent needle stick. |
Teleflex Medical | Jan-11-2012 | DermaHood Neuro Elastic Retractors – Weck; DermaHook (12mm); Neuro Elastic Retractors; 6 per Package; 10 Packages per Sales Units; 10 Sales Units per Shipper; Rx Only; Teleflex Medical; Research Triangle Park; NC 277809.For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. | Teleflex Medical received complaints that the elastic bands are breaking; cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure; loss of the band in the operative field as well as inadvertent needle stick. |
Medical Compression Systems | Jan-11-2012 | ActiveCare +SFT – ActiveCare +SFTMedical Compression SystemsOR Aqiva; ILIntended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis; venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema | This voluntary field action is being undertaken because MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found that an ActiveCare+S.F.T device might cease to work if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product’s User Manual the ActiveCare+S. |
Siemens Healthcare Diagnostics; Inc. | Jan-11-2012 | Dimension(R) Vista(R) V-LYTE(R) – Dimension(R) Vista(R) V-LYTE(R) Diluent (K835)Product Usage: V-LYTE(R) Diluent is for the automatic dilution of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension Vista(R) system | Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IMT sensor. The results can be elevated approximately 10-20% which may cause QC recovery being out of acceptable ranges. Patient Urine sodium results may also b |
AGFA Corp. | Jan-11-2012 | DX-G Digitizer – Agfa Computed Radiography Systems with DX-G Digitizer.DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US; Agfa’s Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography. | Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during startup or during a cassette scan cycle. |
Cypress Medical Products LLC | Jan-11-2012 | Zee Clear Vinyl Medical Examination Gloves; Medium – Zee Clear Vinyl Medical Examination Gloves; Powder Free; Medium; Non-Sterile; 100 gloves per box; 10 boxes per case; Distributed by Zee Medical; Inc.; Irvine; CA 92606; Made in China; Zee Part No.: 3061Single Use; medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants | The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects. |
Allen Medical Systems; Inc. | Jan-11-2012 | Allen C-Flex Head Positioner – Allen C-Flex Head Positioning System non-invasive medical device used to support a patient’s head during spine surgeryCatalog Numbers: A-70700 and A-70701-2 | C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity |
Cypress Medical Products LLC | Jan-11-2012 | Zee Clear Vinyl Medical Examination Gloves; X-Large – Zee Clear Vinyl Medical Examination Gloves; Powder Free; X-Large; Non-Sterile; 100 gloves per box; 10 boxes per case; Distributed by Zee Medical; Inc.; Irvine; CA 92606; Made in China; Zee Part No.: 3063Single Use; medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants | The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects. |
Accuray Incorporated | Jan-11-2012 | CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. – CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option.The CyberKnife treatment is indicated for the treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions; tumors and conditions anywhere in the body when radiation treatment is indicated. | User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery. |
Cypress Medical Products LLC | Jan-11-2012 | Zee Clear Vinyl Medical Examination Gloves; Large – Zee Clear Vinyl Medical Examination Gloves; Powder Free; Large; Non-Sterile; 100 gloves per box; 10 boxes per case; Distributed by Zee Medical; Inc.; Irvine; CA 92606; Made in China; Zee Part No.: 3062Single Use; medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants | The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects. |
PerkinElmer LAS; Inc | Jan-11-2012 | Genetic Screening Processor – The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated; high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. | Malfunction of the GSP disk remover unit may cause a punched disc to remain in the well during the measurement of the plate. This may cause a false negative screening result being reported for 17-OHP; resulting in failure to identify cases of congenital adrenal hyperplasia (CAH). |
Smith & Nephew; Inc. Endoscopy Division | Jan-11-2012 | Smith& Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector – Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE ResectorCatalog Number: 7205962. | Manufacturing issue: The distal tip of the outer sheath (return electrode) may detach and become loose in the joint during use. |
Terumo Cardiovascular Systems Corporation | Jan-11-2012 | CDI 500 Monitor – CDI Blood Parameter Monitoring System 500Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH; PC02 ; P02; K+; oxygen saturation; hematocrit; hemoglobin; and temperature are desired. | In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500; Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been considered a recall at the time it was implemented:Terumo CVS began installing a protective shield (plastic grommet) in the system chassis during manufacture of all |
Terumo Cardiovascular Systems Corporation | Jan-11-2012 | CDI 500 Monitor – CDI Blood Parameter Monitoring System 500Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH; PC02 ; P02; K+; oxygen saturation; hematocrit; hemoglobin; and temperature are desired. | In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500; Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been considered a recall at the time it was implemented:Terumo CVS began installing a protective shield (plastic grommet) in the system chassis during manufacture of all |
Terumo Cardiovascular Systems Corporation | Jan-11-2012 | CDI 500 Monitor – CDI Blood Parameter Monitoring System 500Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH; PC02 ; P02; K+; oxygen saturation; hematocrit; hemoglobin; and temperature are desired. | In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500; Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been considered a recall at the time it was implemented:Terumo CVS began installing a protective shield (plastic grommet) in the system chassis during manufacture of all |
Codman & Shurtleff; Inc. | Jan-11-2012 | Codman – Codman Cranial Access Kit with XylocaineProduct Code: 82-6612 Product Usage:The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. |
Codman & Shurtleff; Inc. | Jan-11-2012 | Codman – Codman Cranial Access Kit – complete with XylocaineProduct Code: 82-6614 Product Usage:The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. |
Terumo Cardiovascular Systems Corporation | Jan-11-2012 | CDI 500 Monitor – CDI Blood Parameter Monitoring System 500Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH; PC02 ; P02; K+; oxygen saturation; hematocrit; hemoglobin; and temperature are desired. | In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500; Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing on older systems should have been considered a recall at the time it was implemented:Terumo CVS began installing a protective shield (plastic grommet) in the system chassis during manufacture of all |
Codman & Shurtleff; Inc. | Jan-11-2012 | Codman – Codman Cranial Disposable Intracranial Pressure (ICP) Kit; Plastic Subarachnoid Screw;; AdultProduct Code:80-1196Product Usage:The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. |
Codman & Shurtleff; Inc. | Jan-11-2012 | Codman – Codman Cranial Disposable Intracranial Pressure (ICP) Kit; Plastic Subarachnoid Screw; Pediatric Product Code:80-1197Product Usage:The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. |
Surgical Appliance Industries | Jan-11-2012 | Truform Therapeutic Classic Medical Style Compression Stockings – Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG; Truform Therapeutic Classic Medical Style Compression Stockings 30-40 mmHG; A Div of SAI; Cincinnati; OH 45209Product Usage: To help relieve tired; heavy legs; and moderate to pronounced varicose veins and swelling. | During an audit with the FDA; it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally; the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s |
Surgical Appliance Industries | Jan-11-2012 | Truform Therapeutic Classic Medical Style Compression Pantyhose – Truform Therapeutic Classic Medical Style Compression Pantyhose 20-30 mmHG; A Div of SAI; Cincinnati; OH 45209Product Usage: To help relieve tired; heavy legs; and moderate to pronounced varicose veins and swelling. | During an audit with the FDA; it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally; the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s |
Codman & Shurtleff; Inc. | Jan-11-2012 | Codman – Codman Cranial Disposable Intracranial Pressure (ICP) Kit; Stainless Steel Subarachnoid ScrewProduct Code:80-1190 Product Usage:The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures. | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. |
Walgreen Company | Jan-11-2012 | Walgreens Quick Read Digital Thermometer – Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model WIC551226 | The thermometers have been reported to have inaccurate readings |
Cincinnati Sub-Zero Products Inc | Jan-11-2012 | Steri-Probe Temperature Probe – Cincinnati Sub Zero; Steri-Probe Temperature Probe; Esophageal/Rectal Temperature Probe; Part Number: 39622; Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/monitoring device to continuously measure/monitor a patient’s core body temperature. | Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device; which the probes connect to; to shut down operation and display a ‘check probe’ error. |
Encore Medical; Lp | Jan-11-2012 | Foundation Non-Porous Hip System – FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mmDJO Surgical 9800 Metric Blvd.; Austin; TX 78758The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis; inflammatory arthritis; traumatic arthritis; rheumatoid arthritis; avascular necrosis; or femoral neck fracture; and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with bone cement. | The sterility has the potential to be compromised. |
Beckman Coulter Inc. | Jan-11-2012 | UniCel DxC and Synchron LX Clinical Systems – UniCel DxC and Synchron LX Clinical Systems 100 L Sample Syringe; 100UL-PKGD; Part Number 474171Product Usage: The UniCel DxC and LX Synchron Clinical Systems are fully automated; computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries; therapeutic drugs; and other chemistries. Analysis can be performed on serum; plasma; urine; or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent). | The recall was initiated because Beckman Coulter has confirmed that the Modular Chemistry (MC) and Cartridge Chemistry (CC) 100 uL sample syringes may experience premature wear as indicated by brown discoloration on the plunger and/or inside the glass syringe barrel. Excessive wear of the 100 uL sample syringe barrel and plunger could lead to leaking and may affect results. |
GE Healthcare; LLC | Jan-11-2012 | GE Healthcare AW Server – GE Healthcare AW Server version 2.0 with release 2.0 – 4.0 A medical software system that allows multiple users to remotely access AWapplications from compatible computers on a network. | 2 Unrelated Software Issues: An incorrect patient name maybe displayed when switching between two Volume Viewer tabs with different patients. Also; if a second patient exam is selected while the application is starting; the second patient’s data will be displayed with the first patient’s name display on the applications tab. |
Abbott Molecular | Jan-11-2012 | Abbott m2000sp Instrument – Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc.; Des Plaines; IL 60018 USA; list 09K14 | Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire. |
Smiths Medical ASD; Inc. | Jan-11-2012 | Hotline Administration Sets – HOTLlNE Disposable Administration Sets; Product Codes L-70Product Usage: Single patient use Sets designed for use by trained medical professionals; in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290); for the warming and delivery of blood and I.V. solutions; at normothermic flow rates of 50 – 5;000 ml/hr. | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
Thomas Medical Products Inc | Jan-11-2012 | SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer – SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer; SafeSheath(R) Worley Telescopic Braided Series; and Situs LDS2 Lead Delivery System – Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M; CSGWORLBC19M; LVI/66-5.5-CR; LVI/66-5.5-RE; LVI/75-5-62-07-HO; LVI/75-5-62-07-HS; LVI/75-5-62-07-MP; LVI/75-5-62-07-RE; LVI/75-5-66-5.5-RE; LVI/Tele/B-60-07-HO; LVI/Tele/B-60-07-HS; LVI/Tele/B-60-07-MP; LVI/Tele/B-60-07-RE; RL065; RL066; RL067; and RL068This device is intended to be used for the introduction of various types of pacing or defibrillator leads and catheters. | Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube. |
Smiths Medical ASD; Inc. | Jan-11-2012 | Hotline Administration Sets – HOTLlNE Disposable Administration Sets;Product Code L-270Product Usage: Single patient use Sets designed for use by trained medical professionals; in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290); for the warming and delivery of blood and I.V. solutions; at normothermic flow rates of 50 – 5;000 ml/hr. | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
Smiths Medical ASD; Inc. | Jan-11-2012 | Hotline Administration Sets – HOTLlNE Disposable Administration Sets;Product Code L-370Product Usage: Single patient use Sets designed for use by trained medical professionals; in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290); for the warming and delivery of blood and I.V. solutions; at normothermic flow rates of 50 – 5;000 ml/hr. | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
Smiths Medical ASD; Inc. | Jan-11-2012 | Hotline Administration Sets – HOTLlNE Disposable Administration Sets;Product Code L-80Product Usage: Single patient use Sets designed for use by trained medical professionals; in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290); for the warming and delivery of blood and I.V. solutions; at normothermic flow rates of 50 – 5;000 ml/hr. | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
Smiths Medical ASD; Inc. | Jan-11-2012 | Level 1 Normothermic Administration Sets – Level 1 Normothermic I.V. Fluid Administration Sets;Product Code D-60HL ;Product Usage: Single patient use sets designed for use by trained medical professionals; in conjunction with Level 1 Fast Flow Fluid Warmers (H1000; H-1025; H-1028; and H-1200); for the warming and delivery of blood and I.V. solutions; at flow rates of 75ml/min – 530 ml/min. | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
Smiths Medical ASD; Inc. | Jan-11-2012 | Level 1 Normothermic Administration Sets – Level 1 Normothermic I.V. Fluid Administration Sets;Product Code DI-60HL ;Product Usage: Single patient use sets designed for use by trained medical professionals; in conjunction with Level 1 Fast Flow Fluid Warmers (H1000; H-1025; H-1028; and H-1200); for the warming and delivery of blood and I.V. solutions; at flow rates of 75ml/min – 530 ml/min. | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
Integra LifeSciences Corp. | Jan-11-2012 | Integra Surgical – Luxtec UltraLite Pro Headlight with 9ft bifurcated cableModel: AX2000BIFProduct Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. | Headlight assembly (module) may become loose and separate from the headband assembly |
Integra LifeSciences Corp. | Jan-11-2012 | Integra Surgical – Luxtec UltraLite Headlight System with 9ft premium bifurcated cableModel: AX2100BIFProduct Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. | Headlight assembly (module) may become loose and separate from the headband assembly |
Integra LifeSciences Corp. | Jan-11-2012 | Integra Surgical – Luxtec UltraLite Headlight System HeadbandModel: AXI375BIFProduct Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. | Headlight assembly (module) may become loose and separate from the headband assembly |
Integra LifeSciences Corp. | Jan-11-2012 | Integra Surgical – Luxtec UltraLite Headlight System with short linkageModel: AX 1375BIFSLProduct Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. | Headlight assembly (module) may become loose and separate from the headband assembly |
Integra LifeSciences Corp. | Jan-11-2012 | Integra Surgical – Luxtec UltraLite Headlight System sweatbandModel: AXI385BIFProduct Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. | Headlight assembly (module) may become loose and separate from the headband assembly |
Integra LifeSciences Corp. | Jan-11-2012 | Integra Surgical – Luxtec UltraLite Headlight System sweatband with short linkageModel: AXI385BIFSLProduct Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. | Headlight assembly (module) may become loose and separate from the headband assembly |
Integra LifeSciences Corp. | Jan-11-2012 | Integra Surgical – Mark II Headlight module-blackModel: 001380LXProduct Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. | Headlight assembly (module) may become loose and separate from the headband assembly |
Integra LifeSciences Corp. | Jan-11-2012 | Integra Surgical – Mark II Headlight module-black with short linkageModel: 001380LXSLProduct Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. | Headlight assembly (module) may become loose and separate from the headband assembly |
Integra LifeSciences Corp. | Jan-11-2012 | Integra Surgical – UltraLite Headlight module-greyModel: 001328Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. | Headlight assembly (module) may become loose and separate from the headband assembly |
Smiths Medical ASD; Inc. | Jan-11-2012 | Hotline Administration Sets – HOTLlNE Disposable Administration Sets; Product Codes L-70NIProduct Usage: Single patient use Sets designed for use by trained medical professionals; in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290); for the warming and delivery of blood and I.V. solutions; at normothermic flow rates of 50 – 5;000 ml/hr. | Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets |
Mani; Inc. – Kiyohara Facility | Jan-11-2012 | MANI Needle and Suture Pack PGA Absorbable – MANI Needle and Suture Pack; 7-0 PGA Absorbable; Model 2091; 30 cm suture and needle; packaged in individual aluminum pack; within tyvek packaging; 12 packages per box; and labeled in part ***Mani; Inc 8-3 Kiyohara Industrial Park Utsunomiya; Tochigi; Japan***For use in short term soft tissue approximation; including use in ophthalmic surgery; but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. |
Mani; Inc. – Kiyohara Facility | Jan-11-2012 | MANI Needle and Suture Pack PGA Absorbable – MANI Needle and Suture Pack; 7-0 PGA Absorbable; Model 2092; 45 cm suture and needle; packaged in individual aluminum pack; within tyvek packaging; 12 packages per box; and labeled in part ***Mani; Inc 8-3 Kiyohara Industrial Park Utsunomiya; Tochigi; Japan***For use in short term soft tissue approximation; including use in ophthalmic surgery; but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. |
Mani; Inc. – Kiyohara Facility | Jan-11-2012 | MANI Needle and Suture Pack PGA Absorbable – MANI Needle and Suture Pack; 6-0 PGA Absorbable; Model 2490; 45 cm suture and needle; packaged in individual aluminum pack; within tyvek packaging; 12 packages per box; and labeled in part ***Mani; Inc 8-3 Kiyohara Industrial Park Utsunomiya; Tochigi; Japan***For use in short term soft tissue approximation; including use in ophthalmic surgery; but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. |
Mani; Inc. – Kiyohara Facility | Jan-11-2012 | MANI Needle and Suture Pack PGA Absorbable – MANI Needle and Suture Pack; 8-0 PGA Absorbable; Model 2090; 30 cm suture and needle; packaged in individual aluminum pack; within tyvek packaging; 12 packages per box; and labeled in part ***Mani; Inc 8-3 Kiyohara Industrial Park Utsunomiya; Tochigi; Japan***For use in short term soft tissue approximation; including use in ophthalmic surgery; but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. |
Mani; Inc. – Kiyohara Facility | Jan-11-2012 | MANI Needle and Suture Pack PGA Absorbable – MANI Needle and Suture Pack; 5-0 PGA Absorbable; Model 3391; 45 cm suture and needle; packaged in individual aluminum pack; within tyvek packaging; 12 packages per box; and labeled in part ***Mani; Inc 8-3 Kiyohara Industrial Park Utsunomiya; Tochigi; Japan***For use in short term soft tissue approximation; including use in ophthalmic surgery; but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. |
Intersurgical Inc | Jan-11-2012 | IS Can Disposable CO2 absorber – The IS Can Disposable CO2 absorber x 6 — Carbon Dioxide absorbent for use on GE rebreathing systems — Manufactured in the United Kingdom for: Intersurgical Incorporated — 417 Electronics Parkway; Liverpool; NY 13088.Intended use: GE Healthcare anesthetic machines: S5 Aespire; S5 Avance; Aisys. The Intersurgical IS Can is for use with air; oxygen; nitrous oxide; halothane; enflurane; isoflurane; desflurane and sevoflurane. | Intersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system. |
Mani; Inc. – Kiyohara Facility | Jan-11-2012 | MANI Needle and Suture Pack PGA Absorbable – MANI Needle and Suture Pack; 6-0 PGA Absorbable; Model 2890; 45 cm suture and needle; packaged in individual aluminum pack; within tyvek packaging; 12 packages per box; and labeled in part ***Mani; Inc 8-3 Kiyohara Industrial Park Utsunomiya; Tochigi; Japan***For use in short term soft tissue approximation; including use in ophthalmic surgery; but not for use in cardiovascular and neurological tissue. | Surgical sutures may be weak and may not function as intended during surgical procedures. |
ConMed Corporation | Jan-11-2012 | STAT 2 Pumpette – STAT 2 Pumpette I.V. Compensating Controller; Catalog/REF No. PS2; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body.The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body.This is a disposable device with a sterile; nonpyrogenic fluid path. | ConMed received 16 complaints for STAT 2 Pumpette? devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette? Compensating Controller on several complaint samples had been assembled incorrectly. |
ConMed Corporation | Jan-11-2012 | STAT 2 Pumpette – STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller; 12" length; Catalog/REF No. P-S2-12; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body.The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body.This is a disposable device with a sterile; nonpyrogenic fluid path. | ConMed received 16 complaints for STAT 2 Pumpette? devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette? Compensating Controller on several complaint samples had been assembled incorrectly. |
ConMed Corporation | Jan-11-2012 | STAT 2 Pumpette – STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller (Needle-Free); 12 length; Catalog/REF No. P-S2-12 N; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body.The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body.This is a disposable device with a sterile; nonpyrogenic fluid path. | ConMed received 16 complaints for STAT 2 Pumpette? devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette? Compensating Controller on several complaint samples had been assembled incorrectly. |
ConMed Corporation | Jan-11-2012 | STAT 2 Pumpette – STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free); 60 Drops/cc; 84 length; Catalog/REF No. P-S2V-60 N; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body.The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body.This is a disposable device with a sterile; nonpyrogenic fluid path. | ConMed received 16 complaints for STAT 2 Pumpette? devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette? Compensating Controller on several complaint samples had been assembled incorrectly. |
ConMed Corporation | Jan-11-2012 | STAT 2 Pumpette – STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free); 20 Drops/cc; 84" length; Catalog/REF No. P-S2V-20 N; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body.The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body.This is a disposable device with a sterile; nonpyrogenic fluid path. | ConMed received 16 complaints for STAT 2 Pumpette? devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette? Compensating Controller on several complaint samples had been assembled incorrectly. |
ConMed Corporation | Jan-11-2012 | STAT 2 Pumpette – STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller; 60 Drops/cc; 84" length; Catalog/REF No. P-S2V-60; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body.The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body.This is a disposable device with a sterile; nonpyrogenic fluid path. | ConMed received 16 complaints for STAT 2 Pumpette? devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette? Compensating Controller on several complaint samples had been assembled incorrectly. |
ConMed Corporation | Jan-11-2012 | STAT 2 Pumpette – STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller; 20 Drops/cc; 84" length; Catalog/REF No. P-S2V-20; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body.The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body.This is a disposable device with a sterile; nonpyrogenic fluid path. | ConMed received 16 complaints for STAT 2 Pumpette? devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette? Compensating Controller on several complaint samples had been assembled incorrectly. |
Adenna Inc | Jan-11-2012 | Phantom black latex powder-free gloves – Phantom-brand Black Latex Powder Free Examination Gloves; 100 gloves by weight; size small and Medium; Product Code PHM912; Lot No. 002-E1LF302-1; Manufacture date JUL 2011; Size SmallProduct Code PHM915; Lot No. 002-E1LF305-1; Manufacture date JUL 2011; Size MediumExamination Disposable Gloves | The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused. |
Varian Medical Systems; Inc. Oncology Systems | Jan-11-2012 | 4D Integrated Treatment Console (4DITC) – Varian brand 4D Integrated Treatment Console (4DITC) v10.2.3; Reference/FSCA Identifier: CP-06873;Model Number: H51; distributed by and manufactured by:Varian Medical Systems Inc.; Palo Alto; CAThe 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters; imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS; planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conical Collimator Verification [BCCV] device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place. | When multiple conical collimator treatment plans are scheduled to be treated in a session; thePlan Label should be displayed on the BCCV dialog box should match the Plan Label on the4DITC. However; the name of the plan is not being updated correctly. |
Synthes USA (HQ); Inc. | Jan-11-2012 | Synthes drill bit for 5.0mm Recon Screws/Large QC – Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical instrument is a non powered hand-held device intended for medical purposes to manipulate tissue; or for use with other devices in orthopedic surgery. | Synthes is initiating a recall of the Drill Bit for 5.0mm Recon Screws with large Quick Coupling due to the potential for the drill stop to slip on the drill bit. |
Varian Medical Systems; Inc. Oncology Systems | Jan-11-2012 | Barcode Conical Collimator Verification (BCCV) – Varian brand Barcode Conical Collimator Verification (BCCV) v1.0; Reference/FSCA Identifier: CP-06873; Model Number: HB; distributed by and/or manufactured by:Varian Medical Systems Inc.; Palo Alto; CAThe 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters; imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS; planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conical Collimator Verification [BCCV] device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place. | When multiple conical collimator treatment plans are scheduled to be treated in a session; thePlan Label should be displayed on the BCCV dialog box should match the Plan Label on the4DITC. However; the name of the plan is not being updated correctly. |
Nurse Assist; Inc | Jan-11-2012 | WELCON TM BRAND – WELCON TM BRAND REORDER NO. 7303 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth; TX 76137 www.nurseassist.comFOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | McKesson Medi-Pak – McKESSON Medi-Pak Urethral Catheter Tray with Red Rubber Catheter Sterile.Single Use.Disposable 20 Trays Per Case Reorder No. 37-232 CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS Marketed by McKesson Corporation McKesson Medical-Surgical; Richmond; VA 23228 Made in the U.S.A. Urethral Catheter Tray with Red Rubber Catheter | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | WELCON TM BRAND – WELCON TM BRAND REORDER NO. 7305 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth; TX 76137 www.nurseassist.comFOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | WELCON TM BRAND – WELCON TM BRAND REORDER NO. 7401 (STERILE) URETHRAL CATHETER KIT With 3 Compartment Plastic Pouch. LOT 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth; TX 76137 www.nurseassist.comURETHRAL CATHETER KIT With 3 Compartment Plastic Pouch | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | WELCON TM BRAND – WELCON TM BRAND REORDER NO. 7402 (STERILE) URETHRAL CATHETER KIT (Female) 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth; TX 76137 www.nurseassist.comURETHRAL CATHETER KIT (Female) | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | WELCON TM BRAND – WELCON TM BRAND REORDER NO. 8012 (STERILE) CATHETER CARE KIT 60 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth; TX 76137 www.nurseassist.comCATHETER CARE KIT | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | WELCON Catheterization Tray – REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis; MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga; Ontario Canada L5L 5Z9 1-905-820-7588Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs – REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis; MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga; Ontario Canada L5L 5Z9 1-905-820-7588Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | Urethal Insertion Tray – REF UT8140 Urethal Insertion Tray Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis; MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga; Ontario Canada L5L 5Z9 1-905-820-7588Urethal Insertion Tray | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs – REF UT8150 Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis; MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga; Ontario Canada L5L 5Z9 1-905-820-7588Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Philips Medical Systems (Cleveland) Inc | Jan-11-2012 | Ingenuity CT System – Ingenuity CT (Computed Tomography) System; 510 (k) #K033326; Model #728326; Serial Numbers: 300005; 300010; 300011; 300012; 300013; 300014; 300015; 300016; 300017; 300018; 300019; 300020 and 300021.Product Usage:The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Component defect. When the user is operating the control panel; he/she may inadvertently activate the wrong switch on the control panel which could; in turn; cause the patient couch to move in an unwanted direction. |
Microgenics Corporation | Jan-11-2012 | ThermoFisher/Microgenics – ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL; Liquid Assayed Cardiac Marker Control; in vitro diagnostic. Catalog Numbers & Description:CAI-XLL; Level L; CAI-XL1; Level 1; CAI-XL2; Level 2; CAI-XL3; Level 3;CAI-XL4; Multi-Pack; CAI-XLS; Sample Pack; | Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges. |
Varian Medical Systems; Inc. Oncology Systems | Jan-11-2012 | ARIA Radiation Oncology – Varian brand ARIA Radiation Oncology; ARIA versions 10.0.39 and below; Reference/FSCA Identifier: CP-06070; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CAProduct Usage:The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter; access; modify; store and archive treatment plan and image data from diagnostic studies; treatment planning; simulation; plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department’s clinical and business information. | Varian received customer complaints involving ARIA Oncology Information Systems;where the Planned Total Dose did not calculate correctly in Physician’s Intent. It was identified that incorrect values were being stored for Planned No. Fractions; leading toan unexpected calculation. |
Nurse Assist; Inc | Jan-11-2012 | McKesson Medi-Pak – McKESSON Medi-Pak Foley Catheter Tray without Catheter For Use With 30 cc Foley Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed by McKesson Corporation McKesson Medical-Surgical; Richmond; VA 23228 Made in the U.S.A. Foley Catheter Tray without Catheter | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | WELCON TM BRAND – WELCON TM BRAND REORDER NO. 7300 (STERILE) URETHRAL CATHETER TRAY w/o Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth; TX 76137 www.nurseassist.comUrethral Catheter Tray without Plastic Catheter | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | WELCON TM BRAND – WELCON TM BRAND REORDER NO. 7301 (STERILE) URETHRAL CATHETER TRAY w/ Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth; TX 76137 www.nurseassist.comUrethral Catheter Tray with Plastic Catheter | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | WELCON TM BRAND – WELCON TM BRAND REORDER NO. 7302 (STERILE) URETHRAL CATHETER TRAY w/ Red Rubber Catheter Caution: Contains Natural Latex 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth; TX 76137 www.nurseassist.comUrethral Catheter Tray with Red Rubber Catheter | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | McKesson Medi-Pak – McKESSON Medi-Pak Urethral Catheter Tray with Plastic Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed by McKesson Corporation McKesson Medical-Surgical; Richmond; VA 23228 Made in the USA Urethral Catheter Tray with Plastic Catheter | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
Nurse Assist; Inc | Jan-11-2012 | WELCON TM BRAND – WELCON TM BRAND REORDER NO. 7304 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth; TX 76137 www.nurseassist.comFOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe | Nurse Assist; Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
GE Healthcare; LLC | Jan-11-2012 | GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. – GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1.The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast; testes; thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal; thoracic; vascular and neurosurgical). | GE Healthcare has recently become aware of a potential safety issue associated with the data of your LOGIQ E9 system that may impact patient safety.1 – User may notice an image from a different patient; or an image from the current patient with title information from a different patient.2 Incorrect measurements/calculations on images; when viewed on the off-line review station. As a re |
Microsoft Corporation Health Solutions Group | Jan-11-2012 | Microsoft Amalga Unified Intelligence System (UIS) – Microsoft Amalga Unified Intelligence System (UIS); This is a software-only device; WHIE Implementation v1.1i. A calculator/data processing module; for clinical use.Intended to provide the clinical user with the ability to view data from multiple; different data systems. | The database may incorrectly match patient data resulting in the incorrect patient data being displayed. This could potentially present a risk to patient safety. |
ConMed Corporation | Jan-11-2012 | STAT 2 I;V. Controller – STAT 2 I.V. Controller; Catalog/REF No. S2; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. For controlling the infusion of Intravenous fluids into the human body. | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates. |
ConMed Corporation | Jan-11-2012 | STAT 2 Extension Set Gravity Flow Controller – STAT 2 Extension Set Gravity Flow Controller; 12" length; Catalog/REF No. S2-12; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. The STAT 2 Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates. |
ConMed Corporation | Jan-11-2012 | STAT 2 – STAT 2 Extension Set Gravity Flow Controller (Needle-Free); 12" length; Catalog/REF No. S2-12N; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. The STAT 2 Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates. |
ConMed Corporation | Jan-11-2012 | STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free); – STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free); 60 Drops/cc; 84" length; Catalog/REF No. S2V-60 N; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates. |
ConMed Corporation | Jan-11-2012 | STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free); – STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free); 20 Drops/cc; 84" length; Catalog/REF No. S2V-20 N; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 —This is a disposable device with a sterile; nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates. |
ConMed Corporation | Jan-11-2012 | STAT 2 Secondary Set Gravity Flow Controller; – STAT 2 Secondary Set Gravity Flow Controller; 20 Drops/cc; 13" length; Catalog/REF No. S2-20 MD; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates. |
ConMed Corporation | Jan-11-2012 | STAT 2 Primary Administration Set Gravity Flow Controller; – STAT 2 Primary Administration Set Gravity Flow Controller; 60 Drops/cc; 84" length; Catalog/REF No. S2V-60; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates. |
ConMed Corporation | Jan-11-2012 | STAT 2 Primary Administration Set Gravity Flow Controller – STAT 2 Primary Administration Set Gravity Flow Controller; 20 Drops/cc; 84" length; Catalog/REF No. S2V-20; STERILE; ASSEMBLED IN MEXICO; CONMED CORPORATION; 525 FRENCH ROAD; UTICA; NY 13502 — This is a disposable device with a sterile; nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates. |
Henry Schein; Inc. | Jan-11-2012 | Maxcem Elite – Maxcem Elite(TM) self-etch/self-adhesive resin cement; Refill Kit; net wt. 10 g; REF/Part # 33872; CLEAR — Refill Kit Contents: 2 Syringes (5 g ea); 10 Automix tips (regular) 4:1; 10 Automix tips (wide) 4:1; 10 Intra-oral tipsDental resin cement. Self-etch; self-adhesive resin cement. High bond strength without adhesive needed. Easy to clean up and can be used with all anterior and posterior ceramics; PFMs; and CAD/CAM materials. Color stable and aesthetic. Works with all substrates from opaque to translucent. | The specific lots of Maxcem Elite Refill Kit appear not to be authentic. |
Ortho-Clinical Diagnostics | Jan-11-2012 | VITROS Chemistry Products Calibrator Kit 16 – VITROS Chemistry Products Calibrator Kit 16; REF 680 1700; 5×1 mL — Ortho-Clinical Diagnostics; Rochester; NY USA — Ortho-Clinical Diagnostics High Wycomber; UK. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5;1 FS Chemistry System; the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF). | Ortho Clinical Diagnostics is recalling Lot 1630 of VITROS? Calibrator Kit 16 because it will not likely meet its specified 12 months of stability. |
Interventional Spine Inc | Jan-11-2012 | Single Use PERPOS PLS System – Single Use PERPOS PLS System; Catalog #9045-01Catalog#9045-01 for Single Use PERPOS PLS System- a sterile; medical device kit consisting of the components: PERPOS Access Needle; PERPOS K-Wires; PERPOS 2-in-1 Drill; PERPOS Tap; PERPOS Device Driver; 4.5mm BONE-LOK PLS Implant; and PERPOS Pull Pin Remover. The kit is used by medical professions to stablize the spine as an aid to fusion through immobilization of the facet joints. | The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine; Inc.; may break during use. |
Interventional Spine Inc | Jan-11-2012 | PERPOS 2-in-1 Drills – PERPOS 2-in-1 Drills; Catalog #6070Component Part #6070 for PERPOS 2-in-1 Drill-a canulated; 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) being placed. The PERPOS 2-in-1 Drill (6070) is sold as either a component of the Single Use PERPOS PLS System (9045-01; 9045-02) or as a stand-alone tool. | The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine; Inc.; may break during use. |
Siemens Medical Solutions USA; Inc | Jan-11-2012 | Siemens syngo Imaging XS; versions VA70A and VA70B Client/Server Installations – syngo Imaging XS; versions VA70A and VA70B Client/Server InstallationsRadiological image processing system | Unintended behavior when using syngo Imaging XS; versions VA70A and VA70B Client/Serve installations. Loading additional images/series from Patient Browser using the thumbnails can cause an unintended deletion of images/series. |
Varian Medical Systems; Inc. Oncology Systems | Jan-11-2012 | Varian Unique Single Energy Linear Accelerator – Varian Unique Single Energy Linear Accelerator; C-Series Clinac or Trilogy; versions 7.x and 8.x; Reference/FSCA Identifier: CP-0661; Model Numbers: H14; H18; H27; H29; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA Varian Unique Single Energy Linear Accelerator: The UNIQUE is a Single Energy Linear Accelerator intended to be used for conventional radiotherapy and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features; safety improvements; and usability improvements. The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions; tumors and conditions anywhere in the body when radiation treatment is indicated. | An event has been reported to Varian which entails excessive connector resistance; which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. |
Terumo Cardiovascular Systems Corporation | Jan-11-2012 | CDI 101 Hematocrit/Oxygen Saturation Monitoring System – CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood’s oxygen saturation; hematocrit and hemoglobin levels is needed. | Terumo is recalling the CDI 101 Hematocrit/Oxygen Saturation Monitoring System because they have not yet submitted a 510(k) to FDA to market the device. |
Varian Medical Systems; Inc. Oncology Systems | Jan-11-2012 | Varian brand High Energy Linear Accelerator – Varian High Energy Linear Accelerator; C-Series Clinac; Reference/FSCA Identifier: CP-06611; Models Numbers: 600C; 600CD; 6EX; DBX; 2100C; 2100CD; 2300CD; 21EX; 23EX; DMX; DHX versions 2.x through 6.x; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA. The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions; tumors and conditions anywhere in the body when radiation treatment is indicated. | An event has been reported to Varian which entails excessive connector resistance; which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. |
Maquet Cardiovascular Us Sales; Llc | Jan-11-2012 | Quadrox iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating – MAQUET QUADROX iD PEDIATRIC -OXYGENATOR:BEQ-HMOD 3000; Made In GermanyThe diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 -2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range; the device oxygenates the blood; removes carbon dioxide and regulates the blood temperature.The utilization period for this device is restricted to six hours. | There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator. |
Kerr Corporation | Jan-11-2012 | Artiste Maverick Tint – Artiste Maverick Tint; Part Number: N36TB; Lot/Serial Numbers: 3416180; Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates.Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. | The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation; please refrain from using the affected product. |
Angiodynamics Worldwide Headquarters | Jan-11-2012 | Benephit – Benephit XT Infusion System; Targeted Renal Therapy Infusion System; Catalog/REF 70035; STERILE — AngioDynamics Inc. 603 Queensbury; NY 12804 USA — COMMON/USUAL NAME – Continuous flush catheter; CLASSIFICATION NAME: Continuous flush catheter; Device Listing # D069932Benephit Infusion Systems are intended to facilitate targeted renal therapy; or TRT; the delivery of physician-specific agents to the kidneys via the renal arteries. The Benephit Infusion Systems are indicated for use in patients undergoing medical; interventional; or surgical procedures; where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit Infusion Systems are also indicated to facilitate TRT in patients who have demonstrated symptoms of acute kidney injury; and whom arterial catheterization for TRT is feasible. | The Benephit XT Infusion System may contain hairline cracks in the sheath hub. |
A M Systems Inc | Jan-11-2012 | A – M Systems ViroMax viral/bacterial filter – ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patientsFor use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable; for single patient use only. | Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together. |
Biomet Sports Medicine | Jan-11-2012 | Artificial Ligament Fixation Device 15mm; 20mm; 25mm; 30mm; & 35mm TI NS Toggleloc; & #7 PE Ziploop – Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 25MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 20MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 30MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 35MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device #7 PE Ziploop (TM) ToggleLoc (TM).Toggleloc anchors are indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction. | Six sizes of ToggleLoc; Artificial Ligament Fixation Device; have been manufactured with the suture pull hole drilled in the wrong location on the device.The ToggleLoc implant is deployed with a suture that pulls the device through the tunnel. The hole being drilled in the wrong location will orient the device to pass through the tunnel with the angled end of the implant first. This may caus |
Midmark Corportation | Jan-11-2012 | Midmark M11 Ultra Steam Sterilizer – Midmark M11 Ultra Steam Sterilizer; Distributed by: Midmark Corporation; 60 Vista Drive; Versailles; Ohio 45380.Sterilize reusable equipment that is heat and moisture stable. | During and FDA inspection on 8/23/2011; it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning. |
Stryker Howmedica Osteonics Corp. | Jan-11-2012 | Eius Unicompartmental Knee System – Eius Unicompartmental Knee SystemStryker Howmedica Osteonics Corp.Howmedica International S. de R.L.; Raheen Business Park; Limerick; Ireland.Intended for use in Unicompartmental Knee Arthroplasty (UKA). Surgeon users have identified the following potential advantages of UKA procedures versus Total Knee Arthroplasty procedures generally: conservation of the opposite compartment; preservation of ligaments and patellofemoral articulation; reduced loss of bone stock and lower implant cost. The EIUS UKA is a Resurfacing device that requires the removal of a thin condylar cross-section intended to replace the diseased cartilage only. This allows the surgeon to conserve good quality subchondral bone. | Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices. |
Therakos; Inc. | Jan-11-2012 | Therakos Cellex Photopheresis System – Therakos Cellex Photopheresis SystemCellexUSA & Cellex.The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestation of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to other forms of treatment. The Cellex procedural kits are designed to interface with the Cellex Photopheresis System to perform cell separation and photo activation in a single closed and sterile circuit. This is accomplished by use of an integrated centrifuge bowl and associated tubing for separation of whole blood into red blood cells; plasma; and buffy coat (leukocyte-enriched blood). All blood components are returned to the patient. The procedural kits are fully assembled as received by the customer and the customer is only required to place the components in the Cellex System to enable the system for use. | There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System. |
Siemens Medical Solutions USA; Inc | Jan-11-2012 | Siemens ARTISTE and ONCOR linear accelerator – ARTISTE and ONCOR linear accelerators with G31 mother board.ARTISTE and ONCOR are manufactured by Siemens Medical Solutions; Roentgenstrasse 19-21; Kemnath; Germany.ARTISTE; ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer. | Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line. |
Smith & Nephew; Inc. Endoscopy Division | Jan-11-2012 | Smith & Nephew SPIDER2 Limb Positioner – Smith & Nephew; SPIDER2 Limb Positioner; including accessories Battery; foot pedal and chargerCatalog Number: 72203299.Table; Operating-room; Pneumatic. | SPIDER2 may unlock (loss of traction) resulting inpotential movement of the patient when the device is within close proximity to an RF source. Lossof traction can potentially result in the unintended repositioning of the extremity and potential for tissue or cartilage damage |
Life Recovery Systems HD; LLC | Jan-11-2012 | Thermosuit – ThermoSuit Manufactured for Life Recovery Systems. HD; LLC; 170 Kinnelon Rd. Kinnelon; NJ 07405 USATel.: (973) 283-2800FAx.: (973) 283-2910Temperature reduction in patients where clinically indicated; Monitoring of patient temperature | ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading. |
Siemens Healthcare Diagnostics; Inc | Jan-11-2012 | ADVIA Centaur CA19-9 Assay – ADVIA Centaur CA19-9 AssayCat. Nos.123521 (03481938) – 250 Test kit w/o Calibrators123519 (04612750) – 50 Test kit w/o Calibrators10491244 – 250 Test kit w/Calibrators10491379 – 50 Test kit w/CalibratorsThe ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen; in human serum; using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined. | Positive bias of 14% and higher for some individual points for CA 19-9 results generated on the ADVIA Centaur CP system when they are compared to CA 19-9 assay results generated on either the ADVIA Centaur or ADVIA Centaur XP systems |
Del Mar Reynolds Medical; Ltd. | Jan-11-2012 | Lifescreen Apnea – Lifescreen Apnea is Lifescreen ECG Screening System; Version 3.31. Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea; mixed apnea or hypopnea; in order to evaluate the necessity for a polysomonographic examination. The ECG recording may be obtained at any location specified by a physician including home; hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. | When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology InformationManagement System; customers can get corruption in the data or a wrong ECG after the first32 hours. Both recordings have to be longer than 32 hours for this to happen. |
Spacelabs Healthcare; Llc | Jan-11-2012 | Ultraview SL Command Module – Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Management System (PCMS) to acquire; monitor; and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire; monitor; and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection; respiration; invasive and noninvasive blood pressure; temperature; oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to an information network for display; recording; editing and analysis. | NIBP pump inside the Ultraview SL Command Module; Model 91496; became loose. The pump is suspended by the air hoses and electrical connections; but there can be enough movement todamage internal components and cause the module to fail. |
Angiodynamics; Inc. | Jan-11-2012 | DuraMax Chronic Hemodialysis Catheter – DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip); DuraMax Stacked Tip 36 cm Str. Basic Kit; Catalog No./REF 10302806; STERILE — AngioDynamics; Inc. 603 Queensbury; NY 12804 USAThe AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. |
Angiodynamics; Inc. | Jan-11-2012 | DuraMax Chronic Hemodialysis Catheter – DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip); DuraMax Stacked Tip 24 cm Str. Basic Kit; Catalog No./REF 10302803; STERILE — AngioDynamics; Inc. 603 Queensbury; NY 12804 USAThe AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. |
Angiodynamics; Inc. | Jan-11-2012 | DuraMax Chronic Hemodialysis Catheter – DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip); DuraMax Stacked Tip 28 cm Str. Basic Kit; Catalog No./REF 10302804; STERILE — AngioDynamics; Inc. 603 Queensbury Avenue; Queensbury; NY 12804 USAThe AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. |
Angiodynamics; Inc. | Jan-11-2012 | DuraMax Chronic Hemodialysis Catheter – DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip); DuraMax Stacked Tip 32 cm Str. Basic Kit; Catalog No./REF 10302805; STERILE — AngioDynamics; Inc. 603 Queensbury Avenue; Queensbury; NY 12804 USAThe AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. |
Angiodynamics; Inc. | Jan-11-2012 | DuraMax Chronic Hemodialysis Catheter – DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip); DuraMax Stacked Tip 22 cm Str. Basic Kit; Catalog No./REF 10302802; STERILE — AngioDynamics; Inc. 603 Queensbury; NY USA 12804.The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. |
Life Technologies Corporation | Jan-11-2012 | SPOT-Light" HER2 CISH Kit – SPOT-Light" HER2 CISH Kit; catalog #84-0150; 20 tests/kit; labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com***Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed; paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. | In vitro diagnostic reagent may be contaminated with a fungal contaminant. |
SCC Soft Computer | Jan-11-2012 | SoftMic GUI versions: 4.0.3.0-4.0.3.15; 4.0.4.1-4.0.4.7. – SoftMic GUI versions: 4.0.3.0-4.0.3.15; 4.0.4.1-4.0.4.7.SoftMic is a laboratory information system to be used in medical research; clinical; and public health laboratories by knowledgeable; trained; and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing; for the purpose of storing; managing; querying; and reporting laboratory data. | On 08/25/2011; SCC Soft Computer initiated a correction on the following SoftMic GUI versions: 4.0.3.0-4.0.3.15; 4.0.4.1-4.0.4.7. For clients using SoftMic Result Entry; when a certain series of keystrokes on the test grid are performed while entering results and statusing a test; the test status may not be maintained upon saving. The status may be removed or copied from another test on the order |
Bausch and Lomb; Incorporated | Jan-11-2012 | Crystalens Accommodating Posterior Chamber Intraocular Lens – Crystalens Accommodating Posterior Chamber Intraocular Lens; AT-50AO.Crystalens Accommodating Posterior Chamber Intraocular LensPMA No.: P030002.The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. | Bausch + Lomb voluntary initiated the recall due to a physician complaint of haze on the Crystalens AOwhich was visualized using an angled beam from a slit lamp during the post-operativeexamination. |
Siemens Medical Solutions USA; Inc | Jan-11-2012 | syngo RT Therapist and syngo RT Therapist – syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS.This correction applies to customers who use the syngo RT Therapist v4.2 or the combination of syngo RT Therapist v4.2 with syngo RT Oncologist v4.2 from Siemens.12/7/2011: Update: Syngo RTT4.2.108 SW contains the same SW content when installed on the syngo Oncologist Workspace (license key controlled). Currently the syngo Oncologist SW version is 4.2.92 P04. By installing this update; the Oncologist will match the RTT version 4.2.108.The intended use of the Siemens branded Artiste; Oncor and Primus family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | The software release will bring current Installed Base system to the forward production version. It is a result of the final system testing addressing several safety issues that are not critical for the safe use of the device and multiple performance defects. |
Hospira Inc. | Jan-11-2012 | 0.9% Sodium Chloride Flush Syringe – 0.9% Sodium Chloride Injection; USP; pre-filled flush solution; for IV Flush only; sterile fluid path; 10 mL Single-Use Syringe with Male Luer Lock; 100 syringes per pack; 4 packs per case; Made in Costa Rica; Hospira; Inc.; Lake Forest; IL 60045 USA; list no. 1978-20lock flush solution | There is particulate matter in the fluid pathway; which has been identified as the same material as the rubber tip of the syringe plunger. |
SCC Soft Computer | Jan-11-2012 | SoftLab – SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8.Product Usage: SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable; trained; and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities; for the purpose of storing; managing; querying; and reporting laboratory data. | On 05/03/2011; SCC Soft Computer; Clearwater; FL; initiated a correction on the following SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. A client reported that results were not flagged correctly. This can occur when a test is ordered in Order Entry; then collected |
Varian Medical Systems; Inc. Oncology Systems | Jan-11-2012 | Eclipse Treatment Planning System – Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34); An Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chartmodule); Reference/FSCA Identifier: CP-05277; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA.The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon; electron and proton beams; as well as for internal irradiation (brachytherapy) treatments. In addition; the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. | An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference pointin RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fractionin Eclipse. |
Biomet Microfixation; Inc. | Jan-11-2012 | iQ Intelligent Device – Box labeled in part; "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON; STAINLESS STEEL; GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE; FL 32218 USA www.biometmicrofixation.com***"The Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for three functions: drill pilot holes; high-speed insertion of 1.5x4mm titanium screws; and high-speed insertion of 1.5x4mm and 1.5x5mm Lactosorb fixation screws provided by Biomet Microfixation. The IQ Intelligent Driver is indicated to aid in the implantation of screws (Drilling holes and inserting screws). | Biomet Microfixation; Inc.; Jacksonville; FL; recalled their IQ Intelligent Device; 72-1000 due to failure of the front bit sensor to detect the correct bit that is installed. When a screw is inserted with the device in drill mode; it is possible for the screw or bone to strip. |
Kerr/pentron Dba Kerr Corporation And Pentron Clinical | Jan-11-2012 | Dental cement under the brand name Cement-It and Natural Elegance – Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It).The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It) are indicated as a luting cement bonding system for porcelain crowns; inlays; and onlays and other dental restorations; including ceramics; metal alloys and composite restoratives. | The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications. |
Beckman Coulter Inc. | Jan-11-2012 | Coulter LH500 Series Analyzer – Coulter LH500 Series Analyzer;Part number: 178832; 178833; 178834.LH 500 Series System Instructions for Use; PN 624602 Rev BA. The COULTER LH 500 Analyzer is a quantitative; automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis. | The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. |
Beckman Coulter Inc. | Jan-11-2012 | Coulter HmX Hematology Analyzer – Coulter HmX Hematology Analyzer; Part number: 6605522; 6605523; 6605524.HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative; automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. | The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. |
Beckman Coulter Inc. | Jan-11-2012 | Coulter HmX Hematology Analyzer with Autoloader – Coulter HmX Hematology Analyzer with Autoloader; Part number: 6605525; 6605526; 6605527.HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative; automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. | The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. |
Beckman Coulter Inc. | Jan-11-2012 | COULTER MAXM Hematology Analyzer – COULTER MAXM Hematology Analyzer/MAXM Hematology Analyzer with AutoloaderPart number: 6705995; 6705996; 6705997/Part number: 6705998; 67059999; 6706000.HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative; automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. | The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. |
OSTEOPORE INTERNATIONAL PTE LTD | Jan-11-2012 | Osteopore – Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C; Osteoplug; and Osteomesh. | Product sterility may be compromised. |
Trumpf Medical Systems; Inc. | Jan-11-2012 | Titan – OR table TITAN Automatic; Surgical Table.Surgical bed with Orthopedic Accessories. | Product is being recalled due to unintended movement on the Titan Tables. |
Trumpf Medical Systems; Inc. | Jan-11-2012 | Titan – OR table TITAN T; Surgical Table.Surgical bed with Orthopedic Accessories. | Product is being recalled due to unintended movement on the Titan Tables. |
Trumpf Medical Systems; Inc. | Jan-11-2012 | Titan – OR table TITAN U; Surgical Table.Surgical bed with Orthopedic Accessories. | Product is being recalled due to unintended movement on the Titan Tables. |
Trumpf Medical Systems; Inc. | Jan-11-2012 | Titan – OR table TITAN UT; Surgical Table.Surgical bed with Orthopedic Accessories. | Product is being recalled due to unintended movement on the Titan Tables. |
Biomet; Inc. | Jan-11-2012 | OSS Cemented IM Stem – OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY.Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications. | Biomet has initiated this action following an investigation which identified that Part 150367; (OSSCemented 1M Stem 13×150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem14x150). |
Trumpf Medical Systems; Inc. | Jan-11-2012 | Titan – OR table TITAN; Surgical Table.Surgical bed with Orthopedic Accessories. | Product is being recalled due to unintended movement on the Titan Tables. |
Maquet Inc. | Jan-11-2012 | Magnus Hybrid operating table columns – Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1 | A component of the Magnus hybrid OR system fails to respond to a position command. |
Varian Medical Systems; Inc. Oncology Systems | Jan-11-2012 | 4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator – 4D Integrated Treatment Console (4DITC) TrueBeam Linear AcceleratorVarian Medical Systems; Palo Alto; CA.The 4DITC is designed to interface to the Varian Clinac Treatment Control System for the purpose of providing verification of treatment parameters; imaging and providing a record of treatment.. The True Beam is a medical linear accelerator which delivers X-ray and electron radiation for sterotactic radiosurgery and therapeutic radiation. | Varian has discovered that on 4D Integrated Treatment Console and TrueBeam; the ad-hoc CIAO(Complete Irradiated Area Outline) calculation results in the CIAO generation that is different from the CIAO in RT Chart. The 4DITC algorithm adds dose for the control point at field edge; which should not be added according to the system specifications. |
Kimberly-Clark Corporation | Jan-11-2012 | Kotex tampons – Kotex Natural Balance Security tampons; regular absorbency; unscented. packaged in 18 count or 36 count retail containers. Consumer Services; Kimberly-Clark Corp. Dept. KNBTR-18; P.O. Box 2020; Neenah; WI 54957-2020 USA.To absorb menstrual or other vaginal discharge. | A limited number of Kotex Natural Balance Security Unscented Tampons; regular absorbency; are being recalled after a raw material contaminated with a bacterium; Enterobacter sakazakii; was found when testing the plunger portion of the applicator. |
Vital Images; Inc. | Jan-11-2012 | Vitrea – Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2; Vitrea Enterprise Suite 1.3; Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1.A medical diagnostic system that allows the processing; review; analysis; communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices. | Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2; 1.3; 6.0; 6.1; including all updates to those versions. |
DePuy Orthopaedics; Inc. | Jan-11-2012 | DePuy Offset Wire Fixation Bolt used in Ace-Fischer External Fixation System – Offset Wire Fixation Bolt; catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag. | DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt. |
Siemens Medical Solutions USA; Inc | Jan-11-2012 | Siemens syngo.plaza – syngo.plazaImage processing system | Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more images of that study may exist which are not shown in the syngo.plaza viewer. |
Siemens Medical Solutions USA; Inc | Jan-11-2012 | Siemens MAMMOMAT Inspiration – MAMMOMAT InspirationFull field digital mammographic x-ray system | Lowering the swivel arm with "object table" while an operator’s or patient’s body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. Therefore attention should be paid when adjusting "object table" height to avoid a possible risk of injury to the operator or the patient.The movement of the swivel arm may also cause an injur |
Heritage Labs International LLC | Jan-11-2012 | Appraise A1C Test Pak Kit (Consumers Life Insurance Company – Appraise A1C Test Pak Kit (Consumers Life Insurance Company); Product K7100; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Appraise A1C (Retail) Collection Kit; – Appraise A1C (Retail) Collection Kit; Product K7050; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Appraise A1C Test Pak Kit (Alere – Appraise A1C Test Pak Kit (Alere); Product K7300; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Appraise A1C Test Pak Kit (Carolina Care Plan) – Appraise A1C Test Pak Kit (Carolina Care Plan); Product K7400; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Appraise Hemoglobin A1c Test – Appraise Hemoglobin A1c Test ; Product K7600; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs Appraise Diabetes A1c Test ; 12 kits – Heritage Labs Appraise Diabetes A1c Test ; 12 kits/shipping carton (Product K7602); each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Reli On Hemoglobin A1c Test (Replacement) – Reli On Hemoglobin A1c Test (Replacement); Product K7603; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs Appraise Diabetes A1c Test ; 24 kits – Heritage Labs Appraise Diabetes A1c Test ; 24 kits/shipping carton (Product K7604); each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructionsBlood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs Appraise A1c Diabetes Home Test – Heritage Labs Appraise A1c Diabetes Home Test ; Product K7609; 24 kits/shipping carton (Product K7609); each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructionsBlood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs Nutrasource NDI (USA) DBS Kit – Heritage Labs Nutrasource NDI (USA) DBS Kit; Product K7610; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Appraise A1c Retail Kit – Appraise A1c Retail Kit; Product K7615; each kit packed in a box and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | NDI Combo Test Pak Omega 3 – NDI Combo Test Pak Omega 3; Product K7616; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | NDI Combo Test Pak Omega 3 – NDI Combo Test Pak Omega 3; Product K7618; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | NDI/Life Extension Microtainer Blood Kit – NDI/Life Extension Microtainer Blood Kit; Product K7625; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Appraise/Heritage Combo Kit – Appraise/Heritage Combo Kit; Product K8100; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Appraise/Heritage Combo A1C & Blood Test Kit; – Appraise/Heritage Combo A1C & Blood Test Kit; Product K8300; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Appraise DBS Test Pak/Moore Medical – Appraise DBS Test Pak/Moore Medical LLC; Product K8301; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies; forms; and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Appraise DBS Kit – Appraise DBS Kit; Product K8302; each kit packed in a bag or envelope. (This kit was previously Product A1773; which is listed separately due to the new part number.) Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | HooperHolmes Health & Wellness – HooperHolmes Health & Wellness; Product K8303; each kit packed in an envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs Appraise DBS Bio Disk Test – Heritage Labs Appraise DBS Bio Disk Test; Product K8304-QNS; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | H & W Principal DBS Collection Kit – H & W Principal DBS Collection Kit; Product K8305; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | University of Michigan DBS Collection Kit – University of Michigan DBS Collection Kit; Product K8306; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Principal Waist Circumference DBS Collection Kit – Principal Waist Circumference DBS Collection Kit; Product K8307; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | University of Mannheim DBS Collection Kit – University of Mannheim DBS Collection Kit; Product K8308; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs University of Michigan Clinical Kit – Heritage Labs University of Michigan Clinical Kit; Product K8311; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Biometric Combo Test Kit – Biometric Combo Test Kit; Product K8500; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Appraise DBS Test Pak/HW-Kronos KROJI – Appraise DBS Test Pak/HW-Kronos KROJI; Product K8603; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Principal Combo Test Pak – Principal Combo Test Pak; Product K8700; each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage LabsBlood-Urine Collection Kit – Heritage Labs Blood/Urine Collection Kit; Product A1100; packed in bags in bulk; 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and a form to accompany the specimen .Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs DBS Urine Collection Kit – Heritage Labs DBS/Urine Collection Kit; Product A1101; packed in bags in bulk; 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and a form to accompany the specimen .Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs St. Jude Childhood Cancer Study kit – Heritage Labs St. Jude Childhood Cancer Study Kit; Product A1185. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0 and blood specimen collection supplies.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Benicomp Supplies Kit – Benicomp Supplies Kit; Product A1740. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and forms packaged in a plastic pouch.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs Wellness Single Kit/Bulk – ; Product A1751; each kit packed in a bag or envelope in bulk; 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs Wellness Kits w/Purple Top; – Heritage Labs Wellness Kits w/Purple Top; Product A1767; each kit packed in a bag or envelope in bulk; 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs Wellness Kits – Heritage Labs Wellness Kits; Product A1768; each kit packed in a bag or envelope in bulk; 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Heritage Labs Wellness Kits; – Heritage Labs Wellness Kits; Product A1769; each kit packed in a bag or envelope in bulk; 50 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Super Valu (Appraise) Combo Kit – Super Valu (Appraise) Combo Kit; Product A1773; each kit packed in a bag or envelope. (This kit has since changed to product A8302; which will be listed separately due to the new part number.) Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies and instructions.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | H & W Research Kit; – H & W Research Kit; Product A1776; each kit packed in a bag or envelope. 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies. Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Rules Based Medicine blood collection kit – Rules Based Medicine blood collection kit; Product A1777; each kit packed in a box; 12 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies. Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | Bravo Wellness Kit; – Bravo Wellness Kit; Product A1778; each kit packed in a bag or envelope. Each kit contains 1 Triad Medium Alcohol Prep Pad; Cat. No. 10-3001; NDC 50730-3001-0; blood specimen collection supplies; and forms.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | The National Children’s Study Adult Blood P1 Mother Kit; – The National Children’s Study Adult Blood P1 Mother Kit; Product A2000; Kit #BB5649523; and A2000T (for training); kit #TA0001801; each kit packed in a bag or envelope; 25 kits/shipping carton; each kit contains 2 Triad Medium Alcohol Prep Pads; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | The National Children’s Study Adult Blood P1 Mother Kit; – The National Children’s Study Adult Blood T1 Mother Kit/Heritage Labs Westat T1 Mother Blood Kit; Product A2010; Kit #BA0057371; and Training Kit; A2010T; Kit #TA0000151; each kit packed in a bag or envelope; 25 kits/shipping carton; and contains 2 Triad Medium Alcohol Prep Pads; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | The National Children’s Study Adult Blood T3 Mother Kit/Heritage Labs Westat T3 Mother Blood Kit; – The National Children’s Study Adult Blood T3 Mother Kit/Heritage Labs Westat T3 Mother Blood Kit; Product A2015; Kit #BA0146946; each kit packed in a bag or envelope; 25 kits/shipping carton; and contains 2 Triad Medium Alcohol Prep Pads; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | The National Children’s Study Adult Blood T1 Father Kit/Heritage Labs Westat T1 Father Blood Kit; – The National Children’s Study Adult Blood T1 Father Kit/Heritage Labs Westat T1 Father Blood Kit; Product A2020; Kit #BA4373185; each kit packed in a bag or envelope; 25 kits/shipping carton; and contains 2 Triad Medium Alcohol Prep Pads; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | The National Children’s Study Adult Hair Collection Kit/Heritage Labs – The National Children’s Study Adult Hair Collection Kit/Heritage Labs Westat Adult Hair Collection Kit; Product A2225; Kit #BL1301873; and Training Kit; Product A2225T; Kit #TL0000001; each kit packed in a bag or envelope; 50 kits/shipping carton; and contains 2 Triad Medium Alcohol Prep Pads; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies.Blood specimen collection | Kits contain recalled Triad alcohol pads |
Heritage Labs International LLC | Jan-11-2012 | The National Children’s Study Adult Nail Collection Kit/Heritage Labs – The National Children’s Study Adult Nail Collection Kit/Heritage Labs Westat Adult Nail Collection Kit; Product A2250; Kit #BJ0136829; and Training Kit; Product A2250T; Kit #TJ0000001; each kit packed in a bag or envelope; 50 kits/shipping carton; and contains 2 Triad Medium Alcohol Prep Pads; Cat. No. 10-3001; NDC 50730-3001-0; and blood specimen collection supplies.Blood specimen collection | Kits contain recalled Triad alcohol pads |