Class I recalls
| Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
| Wolf Medical Supply Inc. | Nov-23-2011 | WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP – Wolf Medical Supply; Inc.; WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP; FILL VOLUME 60 mL; FLOW RATE 2mL/Hr; Model # CT-0020-060 Item # RFC060020. Manufactured by Medpro International (Thailand) Ltd. | Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%). |
| Wolf Medical Supply Inc. | Nov-23-2011 | WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP – Wolf Medical Supply; Inc.; WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP; FILL VOLUME 100 mL; FLOW RATE 2mL/Hr. Model # CT-0020-100 Item # RFC100020. Manufactured by Medpro International (Thailand) Ltd. | Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%). |
| Wolf Medical Supply Inc. | Nov-23-2011 | WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP – Wolf Medical Supply Inc.; WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP; FILL VOLUME 270 mL; FLOW RATE 2mL/Hr. Model # CT-0020-270 Item # RFC270020.Manufactured by Medpro International (Thailand) Ltd. | Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%). |
| Draeger Medical; Inc. | Nov-22-2011 | Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) – Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) – Physiological Patient Monitoring SolutionNetworked solution/system used to monitor patients’ vital signs and therapy; control alarms; review Web-based diagnostic images; access patient records; and scale up functionality based on patient acuity level. | During product training on the Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) it was discovered that the weight-based drug dosage calculation may indicate incorrect recommended values. In addition; a misalignment of ECG and ART waveforms delivered from an Infinity(RO Acute Care System (IACS) Monitoring Solution (M540) was observed on the Infinity Central Station. |
| King International | Nov-10-2011 | Shoulder Flex Massage Device – Shoulder Flex Massage DeviceDevice is an electric personal massage device labeled in part: "ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all instructions before using the massager* **WARNING NEVER wear a necklace or similar items while using this product Made in China."Personal use massage device designed for home use to provide deep tissue massage to the neck; shoulder and back while user lies on a flat surface. | The covered rotating mechanism can catch on user’s clothing; jewelry (e.g. necklace); and hair. There have been reports of one death and a strangulation associated with using the device. |
Class II recalls
| Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
| Del Mar Reynolds Medical; Ltd. | Nov-29-2011 | Ambulatory Blood Pressure (ABP) Monitor – Ambulatory Blood Pressure (ABP) Monitor; Model 90217A.The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small; lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour; 48 hour; or longer period. | If external pressure is applied to the cuff of the Ambulatory Blood Pressure; Model 90217A; during deflation; the monitor will stop working and display an EC75 error code. |
| Terumo Cardiovascular Systems Corporation | Nov-29-2011 | Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray)Product Usage: The 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 CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The felt washer should not have been installed |
| Terumo Cardiovascular Systems Corporation | Nov-29-2011 | Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1Product Usage: The 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 CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The felt washer should not have been installed |
| Terumo Cardiovascular Systems Corporation | Nov-29-2011 | Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1Product Usage: The 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 CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The felt washer should not have been installed |
| Terumo Cardiovascular Systems Corporation | Nov-29-2011 | Advanced Perfusion System 1 – The Terumo Advanced Perfusion System 1; Catalog Number 801763; System 1 Base; 110 VProduct Usage: The 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. | 1 US customer was operating the Advanced Perfusion System 1 with an unapproved; modified cable; which was in product development; to connect the system an an occluder for the Sarns Modular Perfusion System 8000 . Five(5)of twelve(12) cables from Terumo Japan; which were in product development; were given to a US customer. |
| Terumo Cardiovascular Systems Corporation | Nov-29-2011 | Advanced Perfusion System 1 – The Terumo Advanced Perfusion System 1; Catalog Number 801764 System 1 Base; 220 VProduct Usage: The 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. | 1 US customer was operating the Advanced Perfusion System 1 with an unapproved; modified cable; which was in product development; to connect the system an an occluder for the Sarns Modular Perfusion System 8000 . Five(5)of twelve(12) cables from Terumo Japan; which were in product development; were given to a US customer. |
| Acrymed Incorporated | Nov-29-2011 | ON-Q Silver Dressing – ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026.The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed; Inc Beaverton; OR 97008***".Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites. | The Silver Dressing; lot H0705J and H0706J may contain dressings that are not properly sealed in the foil pouch; which could affect sterility of the dressing. |
| Elekta; Inc. | Nov-29-2011 | Medical linear acelerator (with patient imaging) – Elekta Synergy XVI 4.5Product Usage: Radiation therapy treatment of malignant neoplastic diseases; as determined by a licensed medical practitioner. | If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery; Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a a zero value. |
| Terumo Cardiovascular Systems Corporation | Nov-29-2011 | Sarns Modular Perfusion System 8000; Circuit Board for MBattery Module – Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist. | Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single customer. The affected board mislabeled two connection between the board and the transformer. |
| Microgenics Corp | Nov-28-2011 | Multigent Vancomycin Calibrators – Multigent Vancomycin Calibrators;Manufactured by Microgenics Corp; Fremont; CA.Distributed by: Abbott Diagnostics; Abbott Park; IL Product Usage:The Multigent Vancomycin calibrators are inended for use in the calibration of the multigent vancomycinVancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections. | Complaint from the sole distributor that the third party control material is recovering high; and outside the published range. |
| Philips Medical Systems (Cleveland) Inc | Nov-28-2011 | Ingenia 1.5T and 3.0T MRI Systems – Ingenia 1.5T and 3.0T MRI Systems; Model Numbers: 781396 and 781377; 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images; spectroscopic images and/or spectra in any orientation of the internal structure of the head; body; or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra; when interpreted by a trained physician; provide information that may assist the diagnosis. | The firm determined that during scanning procedures; for some larger patients; some reddening of the skin of can occur in certain instances due to RF heating when the torso of the patient is positioned within the body coil. |
| Pelstar; Llc | Nov-28-2011 | Health o Meter Professional – Health o Meter Professional Remote Display Digital Physician Scale; Model 498KL; digital patient weighing scale; Pelstar LLC; 11800 South Austin Avenue; Unit B; Alsip; IL 60803; U.S.A.; Made n China; Model 498KLModel 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate; reliable and repeatable weight measurements and features that make the weighing process simple; fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included). | There is a potential for an electrical short when installing or replacing the batteries in the remote display head of the scales. This short may cause the batteries to smoke; burn or burst. |
| Immunetech Inc | Nov-25-2011 | MyAllergyTest; Specimen Collection Kit – ImmuneTech brand MyAllergyTest; Specimen Collection Kit; Part No. 8001; Individually Packaged Kit; Product is manufactured distributed by ImmuneTech; Inc.; Foster City; CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries; Inc.; Triad Group; Hartland; WIThe MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group; Hartland; WI due to Bacillus cereus; microbial contamination. |
| Immunetech Inc | Nov-25-2011 | MyAllergyTest; Specimen Collection Kit – ImmuneTech brand MyAllergyTest; Specimen Collection Kit; Part No. 8013; Provider Pack: 10 test (with lancet); Product is manufactured distributed by ImmuneTech; Inc.; Foster City; CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries; Inc.; Triad Group; Hartland; WIThe MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group; Hartland; WI due to Bacillus cereus; microbial contamination. |
| Immunetech Inc | Nov-25-2011 | MyAllergyTest; Specimen Collection Kit – ImmuneTech brand MyAllergyTest; Specimen Collection Kit; Part No. 8014; Provider Pack: 10 test (without lancet);Product is manufactured distributed by ImmuneTech; Inc.; Foster City; CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries; Inc.; Triad Group; Hartland; WIThe MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group; Hartland; WI due to Bacillus cereus; microbial contamination. |
| Immunetech Inc | Nov-25-2011 | MyAllergyTest; Specimen Collection Kit – ImmuneTech brand MyAllergyTest; Specimen Collection Kit; Part No. 8015; Screening Pack: 50 test (with lancet);Product is manufactured distributed by ImmuneTech; Inc.; Foster City; CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries; Inc.; Triad Group; Hartland; WIThe MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group; Hartland; WI due to Bacillus cereus; microbial contamination. |
| Immunetech Inc | Nov-25-2011 | MyAllergyTest; Specimen Collection Kit – ImmuneTech brand MyAllergyTest; Specimen Collection Kit; Part No. 8021; Screening Pack: 100 test (with lancet & capillary); Product is manufactured distributed by ImmuneTech; Inc.; Foster City; CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries; Inc.; Triad Group; Hartland; WIThe MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group; Hartland; WI due to Bacillus cereus; microbial contamination. |
| Immunetech Inc | Nov-25-2011 | MyAllergyTest; Specimen Collection Kit – ImmuneTech brand MyAllergyTest; Specimen Collection Kit; Part No. 8024; Provider Pack: 5 test; Product is manufactured distributed by ImmuneTech; Inc.; Foster City; CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries; Inc.; Triad Group; Hartland; WIThe MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing. | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group; Hartland; WI due to Bacillus cereus; microbial contamination. |
| Hospira Inc. | Nov-25-2011 | Hospira LifeShield Latex-Free 150 mL Burette Set – Hospira LifeShield Latex-Free 150 mL Burette Set; with Calibrated Burette and 2 Clave Ports; Convertible Pin; 77 inch ; Soluset Microdrip with Option-Lok; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica; Hospira; Inc.; Lake Forest; IL 60045 USA; list 19208-01Intended use: for the administration of fluids | The float valve in the burette sticks to the burette wall and does not open or close properly. |
| SCC Soft Computer | Nov-23-2011 | SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. – SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. 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 report laboratory data. | On 05/03/2011 SCC Soft Computer; Clearwater; FL initiated a correction on the following SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. A client reported the PT and INR results did not get flagged. The PROT should have been flagged as HIGH and the INR should have been flagged as PANIC. Neither test was flagged. All affected clients were notified of the issue on 05/03 |
| Siemens Medical Solutions USA; Inc. | Nov-23-2011 | Symbia T Series SPECT-CT System – Siemens Medical Solutions USA; Inc.; Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System. | Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems. |
| Siemens Medical Solutions USA; Inc. | Nov-23-2011 | Symbia S Series SPECT System – Siemens Medical Solutions USA; Inc.; Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient’s anatomy. | Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems. |
| Abbott Medical Optics Inc (AMO) | Nov-23-2011 | Sensar Foldable IOL with OptiEdge – Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter.The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag. | The firm is initiating this voluntary recall because of the possibility that certain Sensar IOLs are labeled with an incorrect diopter power. |
| Abbott Medical Optics Inc (AMO) | Nov-23-2011 | Sensar Foldable IOL with OptiEdge – Sensar Foldable IOL with OptiEdge. Model number AR40e; 6.0 Diopter.The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag. | The firm is initiating this voluntary recall because of the possibility that certain Sensar IOLs are labeled with an incorrect diopter power. |
| Draeger Medical; Inc. | Nov-23-2011 | Draeger Infinity(R) Delta; Delta XL; Gamma XXL and Kappa Monitors – Draeger Infinity(R) Delta; Delta XL; Gamma XXL and Kappa Monitors are used to monitor; physiologically; the vital signs of patients (with Arrhythmia Detection or Alarms). | Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements. |
| Steris Corporation | Nov-23-2011 | STERIS 5085 and 5085SRT surgical tables – STERIS 5085 and 5085SRT Surgical Tables; Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6. | Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user’s ability to move the table top out of the full right tilt position. |
| SCC Soft Computer | Nov-23-2011 | Softlab – SCC Soft Computer; Softlab Laboratory information System with DORA versions: 2.0.0.4 with Hot Fix 1.2808; 1.2809; 1.2956; or 1.3476; 2.0.0.5; 2.0.0.6; 2.0.0.7 with Hot Fix 1.6595; and 2.1.0.3. | Potential for patient data to be sent to the wrong patient record. A software change affected how the Softlab handles recovery from certain types of table access conflicts. When such conflicts occur; this function has the potential to cause faulty writing to the database. |
| Varian Medical Systems; Inc. | Nov-23-2011 | Flexible Probe with Blocking Washer – Varian Medical Systems; Flexible Probe with Blocking Water; GM11002420; (Part of the Segmented Cylinder Set; GM11004150) | The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer. |
| International Biophysics Corp | Nov-23-2011 | IBC Suction Wand – IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO; SUITE 275; AUSTIN; TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015For use in open heart procedures; Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems. | Potential for the sterility to be compromised. |
| AGFA Corp. | Nov-23-2011 | AdminTool2 – IMPAX CardioVascular (CV) Admin ToolThe IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. | Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it. |
| Medi-Physics Inc. dba GE Healthcare | Nov-22-2011 | Rapid Strand Rx – Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material; stiffened; loaded into prostate seeding needles; packaged and then sterilized by Gamma sterilization method; accompanied by a calibration strand; a sealed source calibration certificate (100% assay report); a radiograph of the loaded needles in the needle-holding card; and a source certification technical data sheet.; Products Provided by: Oncura; 3350 North Ridge Avenue; Arlington Heights; IL 60004 USA; Prescription Filled by: AnazaoHealth; 5710 Hoover Blvd.; Tampa; FL 33634 USA; product identifier: I125RSRX; model 7000.RAPID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy. | There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy. |
| Uplift Technologies Inc. | Nov-22-2011 | Uplift Commode Assist – "***UPLIFT TECHNOLOGIES INC.***Bringing quality to life.***Model No.***CA200***Description***Lifting commode chair***Weight Range***80-300+ lb-136+ kg***"Labeling on product: "***1C0101 and K0061014***".A lifting commode chair that is self-powered (non-electric) and provides lifting assistance for those who have reduced mobility due to arthritis; post-operative conditions; degenerative joint disease; Parkinson’s disease or other neuromuscular disorders. | On June 26; 2011 Uplift Technologies Inc. Nova Scotia; Canada initiated a recall of the Uplift Commode Assist Model No. CA200; Lot No. 1C0101. The plastic seat does not meet manufacturing specifications. The seat may not fit the unit properly and may interfere with the unit’s normal locking mechanism. |
| Boston Scientific Corporation | Nov-21-2011 | Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths – Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths; Sterile EO; Manufactured by Togo Medikit Co.; Ltd. 17148-6 Aza Kamekawa; Oaza Hichiya; Hyuga City; Miyazaki Prefecture 883-0062; Japan; Distributed by Boston scientific Corporation One Boston Scientific Place; Natick; MA 01760-1537 USA.Super Sheath 8F x 11 cm ;038 with Guide Wire BX/10 UPN H7491603508B1; Catalog # 16035-08B. Batch/Lot 11B15B6; 11B23B7; 11B28B9; 11C09BA; 11C16B9; 11C30B9.Super Sheath 8F x 11 cm ;038 without Guide Wire BX/10 ; U PN M00115724B1; Catalog # 15-724B1. Batch/Lot 11C07B8.Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10; M00159664B1; Catalog # 15-964B; Batch/Lot 11B01B4; 11B25B6.The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature. | Boston Scientific is initiating a medical device recall removal regarding nine lots/batches of Super Sheath and Super Sheath R/O Introducer Sheaths. Boston Scientific was informed through product complaints that the 0.035" ID dilator may be labeled incorrectly as a 0.038" ID dilator. |
| Del Mar Reynolds Medical; Ltd. | Nov-21-2011 | Spacelabs Healthcare Hook-Up kits – PDI Electrode Prep Pads; Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . Hook-up kits that contain the affected alcohol prep pads are as follows:Aria; Kit Part number 23189-010; Kit; Basic hookup; AA;CardioCall; Kit Part number 23189-020; Kit; Hookup; CardioCall;Aria; Kit Part number 23189-106; Kit; Aria Hookup;Aria; Kit Part number 23189-110; Kit; Aria Hookup;Flashcorder; Kit Part number 23189-111; Kit; Flashcorder Hookup;Aria; Kit Part number 23189-113; Holter Hookup Kit 7 electrode;LifeCard 12; Kit Part number 23189-114; Kit; Hookup; LC12; Multilingual;Aria; Kit Part number 23189-115; Kit; Basic Hookup; AAA;LifeCard; Kit Part number 23189-116; Kit; Holter Hookup; LifeCard;483; Kit Part number 23189-117; Kit; Holter Hookup 483;Aria; Kit Part number 23189-153; Holter Hookup Kit; 7 electrode;Aria VLC; Kit Part number 23189-207; Kit; Aria Hookup; VLC;EVO; Kit Part number 50-0048; 4 electrode hookup kit without pouch;EVO; Kit Part number 50-0049; 4 electrode hookup kit with pouch;EVO; Kit Part number SK10456; Sample Kit; Disposables.A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1;1;2-trichloro-1;2;2-trifluoroethane; 1;1;1-trichloroethane; and 1;1;1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape. | The non-sterile alcohol prep pads (B339) are included in Spacelabs Healthcare hook-up kits may have the presence of a bacterium; Bacillus cereus. These alcohol prep pads were manufactured and recalled by Professional Disposables International (PDI). |
| Stryker Endoscopy | Nov-21-2011 | SERFAS – Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300; | An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011. |
| SCC Soft Computer | Nov-21-2011 | SoftLab – Software: SA BASE 3.1.4.x; 3.1.6.x and SA LabMic 4.0.0.x; 4.0.1.x; 4.0.2.x; 4.0.3.x; 4.0.4.x. 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 08/08/2011 SCC Soft Computer; Clearwater; FL initiated a correction on following SoftLab used with: SA BASE 3.1.4.x; 3.1.6.x and SA LabMic 4.0.0.x; 4.0.1.x; 4.0.2.x; 4.0.3.x; 4.0.4.x. A client reported a flagging error where the result was flagged as critical in the Instrument Menu but the printed report did not show the corresponding flag. All affected clients were notified of the issue on 0 |
| C P Medical Inc. | Nov-19-2011 | Mono-Dox Synthetic Absorbable Suture – Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. The product is a Violet; monofilament synthetic absorbable suture with needle; size 4/0 (1.5 Metric); NFS-2 Needle (Product code M397-Polydioxanone) or size 3/0 (2.0 Metric) (Product code M398 {Butler code 029254}).Product is labeled in part: "***POLYDIOANONE Violet (PDO) Monofilament Absorbable Suture***".Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur; and ophthalmic surgery. The suture is not recommended for adult cardiac tissue; microsurgery or neural tissue. The absorbable sutures are useful where extended wound support is desirable. | The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch. |
| C P Medical Inc. | Nov-19-2011 | Polyglycolic Acid (PGA) Absorbable Suture – Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. The product is a Violet; monofilament synthetic absorbable suture with needle; size 3/0 (2.0 Metric); NFS-2 Needle (Product code 398A-Polyglycolic Acid) or size 2/0 (3.0 Metric) NFS-1 Needle. (Product code 453A-Polyglycolic Acid).Product is labeled in part: "***NFS-1***CUTTING***Coated POLYGLYCOLIC ACID Violet (PGA) Braided Absorbable Suture STERILE***Manufacturer CP Medical***".Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur; and ophthalmic surgery. The suture is not recommended for adult cardiac tissue; microsurgery or neural tissue. The absorbable sutures are useful where extended wound support is desirable. | The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch. |
| Philips Medical Systems | Nov-19-2011 | SKYLight Gamma Camera System – SKYLight Gamma Camera System;SKYLIGHT; 3/8";SPECT;Manufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | SKYLight Gamma Camera System – SKYLight Gamma Camera System;SKYLIGHT; 5/8";SPECT;Manufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | SKYLight Gamma Camera System – SKYLight Gamma Camera System;SKYLIGHT;AZ;8FT;3/8Manufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | SKYLight Gamma Camera System – SKYLight Gamma Camera System;SKYLIGHT;AZ;8FT;5/8Manufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | SKYLight Gamma Camera System – SKYLight Gamma Camera System;SKYLIGHT;AZ;9FT;5/8Manufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | Precedence System – Precedence System;SYST;PRECEDENCE; 16 SLICE 5/8Manufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | Precedence System – Precedence System;SYST;PRECEDENCE; 16 SLICE 3/8Manufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | Precedence System – Precedence System;SYST;PRECEDENCE; 6 SLICE 3/8Manufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | Precedence System – Precedence System;SYST;PRECEDENCE; 6 SLICE 5/8Manufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | SKYLight Gamma Camera System – SKYLight Gamma Camera System;SKYLIGHT 8FT; 5/8" SPECTManufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | SKYLight Gamma Camera System – SKYLight Gamma Camera System;SKYLIGHT 8FT; 3/8" SPECTManufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Philips Medical Systems | Nov-19-2011 | SKYLight Gamma Camera System – SKYLight Gamma Camera System;SKYLIGHT;AZ;9FT;3/8Manufactured by Philips Medical Systems (Cleveland); Inc.595 Miner Road; Cleveland; OH 44143.The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| AGFA Corp. | Nov-18-2011 | Results Management (RM) Reporting Module – IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. | Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable. |
| AGFA Corp. | Nov-18-2011 | IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) – IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting. | Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR). |
| Cooper Surgical; Inc. | Nov-18-2011 | DICOM Option for the Norland Illuminatus Software Revs – DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600; XR-800; XR-46; EXCELL; XR-36 and Eclipse DXA Bone Densitometers.The XR 46 performs DXA scans of the AP Spine; Hip; Forearm; Lateral Spine; and Whole Body; as well as other user selectable sites. It provides BMD (g/cm2); Area (cm2); and BMC (g) values. It compares these values to gender and ethnic matched reference populations and provides T-Score and % young Reference; Z- Score and % age matched; and long term and short term change values. This includes sBMD (mg/cm2). The XR 46 performs soft tissue assessment and provides lean mass; fat mass; percent fat; and total soft tissue values for all scan sites; including Whole Body. The XR 46 includes a Report writer that allows the operator to customize the appearance of their report stand to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their report for each of these ranges. The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk. | The DICOM Software; Norland Illuminatus DXA Software with the DICOM Option (Part Number 434A133) version 4.2.0 through 4.3.1; which is installed on the XR-600; XR-800; XR-46 and EXCELL DXA Bone Densitometers; could lead to improper patient information getting into a previous patient’s record. |
| Cyberonics; Inc | Nov-18-2011 | VNS Therapy Aspire HC Generator and VNS – VNS Therapy Aspire HC Generator and VNS; Model 105Cyberonics; Inc. 100 Cyberonics Blvd.; Houston; TX 77058For implantation in humans to treat Epilepsy and Depression. | The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation. |
| Medical Device Technologies; Inc. | Nov-18-2011 | T-Lok Bone Marrow Tray – Angiotech***T-Lok Bone Marrow Tray***1 – #11 Mini Scalpel; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – 6/7 Dram Snap Cap Vials-Amber; 1 – Specimen Label; 1 – Stirring Rod; 1 8ga x 4" Bone Marrow Needle "J" Type; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – CSR Wrap; 1 – Fenestrated Drape; 1 – 1% Lidocaine (5mL); 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 – 4mL Specimen Tube w/EDTA; 1 – Probe Guide; 1 – Obturator; 1 – Male Luer Cap; 1 – T-Lok Extraction Cannula; 1 – Towel; 1 – 2"x3" ADH Dressing; 10 – Micro Slides – Frosted end; 1 – Glass Slide Poly Bag***Catalog Number: BMT0804ATL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Bone Marrow Tray – Angiotech***Bone Marrow Tray***1 – 20cc Syringe L/L; 1 – 5cc Syringe L/L; 1 – 19ga x 1-1/2" Filter Needle; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 1% Lidocaine (5mL); 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 – 4mL Specimen Tube w/EDTA; 1 Amber Specimen Bottle w/ Cap; 1 – Specimen Label; 1 – #11 Mini Scalpel; 10 – Micro Slides – Frosted end; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – Stirring Rod; 1 – 2"x3" ADH Dressing; 1 – Towel; 1 – Fenestrated Drape; 1 – CSR Wrap ***Catalog Number: BMT1000***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | T-Lok Bone Marrow Tray – Angiotech***T-Lok Bone Marrow Tray***1 – #11 Mini Scalpel; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 -11ga x 4" Bone Marrow Needle "J" Type; 1 – 6/7 Dram Snap Cap Vials-Amber; 1 – Specimen Label; 1 – Stirring Rod; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – CSR Wrap; 1 – Fenestrated Drape; 1 – 1% Lidocaine (5mL); 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 – 4mL Specimen Tube w/EDTA; 1 -Probe Guide; 1 – Obturator; 1 – Male Luer Cap; 1 – T-Lok Extraction Cannula; 1 – Towel; 1 – 2"x3" ADH Dressing; 10 – Micro Slides – Frosted end; 1 – Glass Slide Poly Bag***Catalog Number: BMT1104ATL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | T-Lok Bone Marrow Tray – Angiotech***T-Lok Bone Marrow Tray***1 – #11 Mini Scalpel; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – Specimen Label; 1 – Stirring Rod; 1 – 11ga x 4" Bone Marrow Needle "J" Type; 1 – 15ga x 2.688" Bone Marrow Needle "I" Type; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 10 – Micro Slides – Frosted end; 1 – Fenestrated Drape; 1 – 1% Lidocaine (5mL); 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 – Probe Guide; 1 – Obturator; 1 – Male Luer Cap; 1 – T-Lok Extraction Cannula; 2 – 4mL Specimen Tube w/EDTA; 1 – Towel; 1 – 2"x3" ADH Dressing; 1 – 6/7 Dram Snap Cap Vials-Amber; 1 -Glass Slide Poly Bag; 1 – CSR Wrap; ***Catalog Number: BMT1104BTL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | T-Lok Bone Marrow Tray w/ Safety Needles – Angiotech***T-Lok Bone Marrow Tray w/ Safety Needles***1 – #11 Retractable Scalpel; 1 – 21ga x 1-1/2" Safety Needle; 1 – 25ga x 5/8" Safety Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – 11ga x 4" Bone Marrow Needle "J" Type; 1 – Specimen Label; 5 – 3" x 3" Sponges (4-Ply); 1 – CSR Wrap; 1 – 6/7 Dram Snap Cap Vials-Amber; 1 – Stirring Rod; 1 – Fenestrated Drape; 1 – 1% Lidocaine (5mL); 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 – 4mL Specimen Tube w/EDTA; 1 – Probe Guide; 1 -Obturator; 1 – Male Luer Cap; 1 – T-Lok Extraction Cannula; 1 – 2"x3" ADH Dressing; 10 – Micro Slides – Frosted end; 1 – Towel; 3 – NeedleVISE***Catalog Number: BMT1104STL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | T-Lok Bone Marrow Tray – Angiotech***T-Lok Bone Marrow Tray***1 – #11 Mini Scalpel; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – 11ga x 4" Bone Marrow Needle "J" Type; 1 – 16ga x 2.688" Bone Marrow Needle "I" Type; 1 – 6/7 Dram Snap Cap Vials-Amber; 1 – Specimen Label; 1 – 2"x3" ADH Dressing; 10 – Micro Slides – Frosted end; 1 – Fenestrated Drape; 1 – 1% Lidocaine (5mL); 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 – 4mL Specimen Tube w/EDTA; 1 Probe Guide; 1 -Obturator; 1 – Male Luer Cap; 1 T-Lok Extraction Cannula; 1 – Towel; 1 – Stirring Rod; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – Glass Slide Poly Bag; 1 – CSR Wrap***Catalog Number: BMT1104TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Bone Marrow Tray – Angiotech***Bone Marrow Tray***1 – 20cc Syringe L/L; 1 – 5cc Syringe L/L; 1 – 19ga x 1-1/2" Filter Needle; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 15ga x 2.688" Bone Marrow Needle "I" Type; 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 – 4mL Specimen Tube w/EDTA; 10 – Micro Slides – Frosted end; 1 – 1% Lidocaine (5mL); 1 – #11 Mini Scalpel; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – 2"x3" ADH Dressing; 1 – Towel; 1 – Fenestrated Drape; 1 – Amber Specimen Bottle w/ Cap; 1 – Specimen Label; 1 – Stirring Rod; 1 – CSR Wrap***Catalog Number: BMT1501***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Bone Marrow Tray – Angiotech***Bone Marrow Tray***1 – 20cc Syringe L/L; 1 – 5cc Syringe L/L; 1 – 19ga x 1-1/2" Filter Needle; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 16ga x 2.688" Bone Marrow Needle "I" Type; 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 – 4mL Specimen Tube w/EDTA; 10 – Micro Slides – Frosted end; 1 – 1% Lidocaine (5mL); 1 – #11 Mini Scalpel; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – 2"x3" ADH Dressing; 1 – Towel; 1 – Fenestrated Drape; 1 – Amber Specimen Bottle w/ Cap; 1 – Specimen Label; 1 – Stirring Rod; 1 – CSR Wrap***Catalog Number: BMT1601***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray – Angiotech***Custom Bone Marrow Tray for New York Hospital/Cornell Medical Center*** 1 – 18ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 22ga x 1-1/2" Needle; 1 – 21ga x 1-1/2" Needle; 1 – 20cc Syringe L/L; 1 – 10cc Syringe L/L; 2 – 10cc Syringe L/S; 1 – Obturator; 1 – Male Luer Cap; 20 – Micro Slides – Frosted end; 1 – T-Lok Extraction Cannula; 1 – 11ga x 4" Bone Marrow Needle "J" Type; 4 – Ampule Breaker; 2 – 10% Povidone Iodine Swab Sticks (3/Pkg); 2 – 4mL Specimen Tube w/EDTA; 1 – Long Handle Scalpel; 4 – 3" x 3" Sponges in stacks of 5 (4-Ply); 4 -Alcohol Swab Sticks; 4 – 1% Lidocaine (5mL); 1 – 2"x3" ADH Dressing; 3 – Towels; 1 – Probe Guide; 1 – Fenestrated Drape; 1 – CSR Wrap; 1 – 19ga x 1-1/2" Filter Needle ***Catalog Number: CB0033TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray – Angiotech***Custom Bone Marrow Tray for University of Chicago*** 2- 20ga x 1 ¿" Safety Needle; 1 21ga x 1-1/2" Safety Needle; 1 25ga x 5/8" Safety Needle; 1 – 10cc Syringe L/L; 2 – 20cc Syringe L/L; 3 – 4" x 4" Sponges in stacks of 5; 2 – 3" x 3" Sponges in stacks of 5; 1 – CSR Wrap; 2 – Fenestrated Drape; 1 – 5" Hemostat Straight Mosquito; 1 – #11 Retractable Scalpel; 1 – 8ga x 4" Bone Marrow Needle "J" Type; 1 – 16ga x 2.688" Bone Marrow Needle "I" Type; 1 – Probe Guide; 1 – Male Luer Cap; 1 – T-Lok Extraction Cannula; 1 – Obturator; 2 – Petri Dish***Catalog Number: CB00541TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray – Angiotech***Custom Bone Marrow Tray for University of CA; Davis*** 1 – 10cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – 19ga x 1-1/2" Filter Needle; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 8ga x 4" Bone Marrow Needed "J" Type; 1 15ga x 4" Bone Marrow Needle "I" Type; 1 – T- Lok Extraction Cannula; 1 – 10% Providone Iodine Swab Sticks (3/Pkg.); 1 – Probe Guide; 1 – Obturator; 2 – 1% Lidocaine (5mL); 1 – #11 Mini Scalpel; 2 – 4" x 4" Sponges in stacks of 5; 1 – 2" x 3" ADH Dressing; 1 – Towel; 1 – Fenestrated Drape; 1 – Male Luer Cap; 1 – CSR Wrap***Catalog Number: CB0140TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physicianMEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray – Angiotech***Custom Bone Marrow Tray*** 1 – #11 Mini Scalpel; 1 – 20ga x 1-1/2" Needle; 1 – 23ga x 1" Needle; 1 – 18ga x 3-1/2" Needle; 1 – 25ga x 5/8" Needle; 3 – 10cc Syringe L/S; 2 – 1% Lidocaine (5mL); 1 – Male Luer Cap; 1 – Fenestrated Drape; 1 – CSR Wrap; 1 10% Providone Iodine Swab Sticks (3/Pkg.); 3 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 2" x 3" ADH Dressing; 1 – Towel; 1 – 15ga x 2.688" Bone Marrow Needle "I" Type; 1 – 11ga x 4" Bone Marrow Needed "J" Type; 1 – Probe Guide; 1 – Obturator; 1 – T-Lok Extraction Cannula***Catalog Number: CB0181TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physicianMEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray – Angiotech***Custom Bone Marrow Tray for Kaiser Foundation Hospitals*** 1 – #11 Mini Scalpel; 1 – 21ga x 1-1/2" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 25ga x 1-1/2" Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – Male Luer Cap; 1 – CSR Wrap; 1 – 10% Providone Iodine Swab Sticks (3/Pkg.); 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – 2" x 3" ADH Dressing; 1 – Towel; 1 – Stirring Rod; 1 – 11ga x 4" Bone Marrow Needle "J" Type; 1 – Probe Guide; 1 – Obturator; 1 – T-Lok Extraction Cannula; ***Catalog Number: CB0187TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray – Angiotech***Custom Bone Marrow Tray for Tyler Hematology Oncology*** 1 – #11 Mini Scalpel; 1 – 21ga x 1-1/2" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 25ga x 5/8" Needle; 1 – 25ga x 1-1/2" Needle; 1 – 10cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – Male Luer Cap; 1 – CSR Wrap; 1 – 10% Providone Iodine Swab Sticks (3/Pkg.); 1 – 4" x 4" Sponges in stacks of 5; 1 – 2" x 3" ADH Dressing; 2 – Towel; 1 – 2% Lidocaine (10mL); 1 – 11ga x 4" Bone Marrow Needle "J" Type; 1 – Probe Guide; 1 – Obturator; 1 – T-Lok Extraction Cannula; ***Catalog Number: CB0202TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray – Angiotech***Custom Bone Marrow Tray*** 1 – #11 Mini Scalpel; 1 -Fenestrated Drape; 1 – 21ga x 1-1/2" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 25ga x 5/8" Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – Probe Guide; 1 – Obturator; 1 – Male Luer Cap; 1 – 10% Providone Iodine Swab Sticks (3/Pkg.); 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – 2" x 3" ADH Dressing; 1 -Towel; 1 – 15ga x 4" Bone Marrow Needle "I" Type; 1 – 2% Lidocaine (10mL); 1 – 8ga x 4" Bone Marrow Needle "J" Type; 1 – T_Lok Extraction Cannula; 1 – CSR Wrap***Catalog Number: CB0356TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray for Hackensack University Medical Center – Angiotech***Custom Bone Marrow Tray for Hackensack University Medical Center*** 1 – Fenestrated Drape; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle;1 – 5cc Syringe L/L; 2 -10cc Syringe L/L; 1 – Male Luer Cap; 1 – Glass Slide Poly Bag; 1 – 10% Povidone Iodine Swab Sticks (3/Pkg); 1 – 1% Lidocaine (5mL); 1 – 2" x 3" ADH Dressing; 1 – Towel; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 10 – Micro Slides Frosted end; 1 – 15ga x 2.688" Bone Marrow Needle "I" Type; 1 – CSR Wrap***Catalog Number: CB0370***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray – Angiotech***Custom Bone Marrow Tray for High Point Regional Hospital*** 1 – #11 Mini Scalpel; 1 – Fenestrated Drape; 1 – 20ga x 1-1/2" Needle; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle;1 – 5cc Syringe L/L; 1 – 10cc Syringe L/L; 3 – 20cc Syringe L/L; 1 – Probe Guide; 1 – 10% Povidone Iodine Swab Sticks (3/Pkg); 3 – 4" x 4" Sponges in stacks of 5; 1 – Towel; 1 – 2" x 3" ADH Dressing; 1 – Specimen Label; 1 – Obturator; 1 – Male Luer Cap; 1 – 11ga x 4" Bone Marrow Needle "J" Type; 1 – T-Lok Extraction Cannula; 1 – CSR Wrap***Catalog Number: CB0387TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom General Biopsy Tray – Angiotech***Custom General Biopsy Tray for Emory University Hospital*** 1 – CSR Wrap 48" x 48"; 1 – Fenestrated Drape; 4 -10cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – Chloraprep Applicator (3ml); 2 – 2% Lidocaine (10mL); 2 – Towel; 1 – ¿" x 3" Bandage; 1 – Needle Safety Foam Block; Large; 6 – Specimen Label; 1 – Scalpel #11; 1 – 25ga x 5/8" Needle w/ Safety Glide; 1 – 21ga x 1-1/2" Needle w/ Safety Glide; 1 – 5 Curved Hemostat; 2 – 4" x 4" Sponges in stacks of 5; 1 -19ga x 1-1/2" Filter Needle; 1 – 5cc Syringe L/L; 1 – Ruler with Protractor***Catalog Number: CG00548***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom General Biopsy Tray – Angiotech***Custom General Biopsy Tray for University of Rochester Medical Center***1 – Fenestrated Drape; 1 – 19ga x 1-1/2" Filter Needle; 1 – 22ga x 1-1/2" Needle; 1 – 25ga x 1-1/2" Needle; 1 – 10cc Syringe L/L; 1 – 10% Providone Iodine Swab Sticks (3/Pkg.); 2 – 1% Lidocaine (5mL); 1 – ¿" x 3" Bandage; 1 – Towel; 1 – CSR Wrap; 1 – Lidocaine Insert; 1 – Ruler with Protractor; 1 – 4" x 4" Sponges in stacks of 5***Catalog Number: CG00552***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom General Biopsy Tray – Angiotech***Custom General Biopsy Tray for OMA North of Oklahoma City*** 1 – 60cc Syringe; 2 – 10cc Syringe L/L; 1 -18ga x 1-1/2" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 20ga x 1-1/2" Needle; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 50cm Extension Tube; 1 – 10% Povidone Iodine Swab Sticks (3Pkg); 1 – 1% Lidocaine (5mL); 1 – 3" x 3" Sponges is stacks of 5 (4-Ply); 1 – Fenestrated Drape; 1 – Towel; 1 – CSR Wrap***Catalog Number: CG0072***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom General Biopsy Tray – Angiotech***Custom General Biopsy Tray for Palos Community Hospital*** 1 – #11 Mini Scalpel; 1 – Fenestrated Drape; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 -18ga x 5cm Blunt Needle; 2 – 10cc Syringe L/L; 1 – 10% Povidone Iodine Swab Sticks (3/Pkg); 2 – 1% Lidocaine (5mL); 1 – Ruler; 1 – Screw Type Needle Stop; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – Alcohol Swab Sticks; 1 – 3/4" x 3" Bandage; 2 – Towel; 1 – Specimen Label; 1 – Needle Safety Foam Block; Small; 1 – CSR Wrap***Catalog Number: CG0188***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom General Biopsy Tray – Angiotech***Custom General Biopsy Tray for St. Johns Mercy Hospital*** 1 – #11 Mini Scalpel; 1 – Fenestrated Drape; 1 -21ga x 1-1/2 Needle; 1 – 25ga x 5/8 Needle; 1 – 19ga x 1-1/2 Filter Needle; 1 – 10% Povidone Iodine Swab Sticks (3/Pkg); 2 – 1% Lidocaine (5mL); 1 – Specimen Label; 1 – 10cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – 3 x 3 Sponges in stacks of 5 (4-Ply); 1 – ¿ x 3 Bandage; 1 – Towel; 1 – CSR Wrap***Catalog Number: CG0236***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom General Biopsy Tray – Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 1 – #11 Mini Scalpel; 1 – Fenestrated Drape; 1 – 19ga x 1-1/2" Filter Needle; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – Needle Safety Foam Block; 2 – 10cc Syringe L/L; 4 – Towel; 1 – Ruler; 1 – 4" x 4" Sponges in stacks of 5; 1 – ¿" x 3" Bandage; 1 – 10% Povidone Iodine Swab Sticks (3/Pkg); 1 – 2% Lidocaine (10mL) ; 1 – CSR Wrap***Catalog Number: CG0287***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom General Biopsy Tray – Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 4 -Towel; 1 -19ga x 1-1/2" Filter Needle; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – Needle Safety Foam Block; 2 – 10cc Syringe L/L; 1 – Ruler; 2 4" x 4" Sponges in stacks of 5; 1 – ¿" x 3" Bandage; 1 – 10% Povidone Iodine Swab Sticks (3/Pkg); 2 -1% Lidocaine (5mL); 1 – CSR Wrap***Catalog Number: CG0305***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | General Biopsy Tray – Angiotech***General Biopsy Tray*** 1 – 20cc Syringe L/L; 1 – 10cc Syringe L/L; 1 – 5cc Syringe L/L; 1- 25ga x 5/8" Needle; 1 – 21ga x 1-1/2" Needle;1- 19ga x 1-1/2" Filter Needle; 1 – 10% Povidone Iodine Swab Sticks (3/Pkg); 1 – 1% Lidocaine (5mL); 1 – #11 Mini Scalpel; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – ¿" x 3" Bandage; 2 – Towel; 1 – Fenestrated Drape; 2 – 15mL Specimen Tube; 2 – Specimen Label; 1 – Ruler; 1 – CSR Wrap***Catalog Number: GUTS1000***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray – Angiotech*** Custom Bone Marrow Tray for Louis Weiss Memorial Hospital***1 – #11 Mini Scalpel; 1 – 20ga x 1-1/2" Needle; 1 – 21ga x 1-1/2" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 25ga x 5/8" Needle; 1 – 1cc Syringe L/L; 1 – 5cc Syringe L/L; 2 – 10cc Syringe L/L; 1 Needle Safety Foam Block; Large; 1 – Fenestrated Drape; 1 – Male Luer Cap; 1 – CSR Wrap; 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 – 4" x 4" Sponges in stacks of 5; 1 – 2"x 3" ADH Dressing; 1 – Towel; 4 Alcohol Swab Sticks; 20 – Micro Slides – Frosted end; 1 – T-Lok Extraction Cannula; 1 – 2% Lidocaine (10mL); 1 – 11ga x 4 Bone Marrow Needle J Type; 1 – Probe Guide; 1 Obturator.***Catalog Number: CB0318TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | Custom Bone Marrow Tray – Angiotech*** Custom Bone Marrow Tray***1 – #11 Mini Scalpel; 1 – Fenestrated Drape; 1 – 21ga x 1-1/2" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 25ga x 5/8" Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – Probe Guide; 1 Obturator; 1 – Male Luer Cap; 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – 2"x 3" ADH Dressing; 1 – Towel; 1 15ga x 4" Bone Marrow Needle "I" Type; 1 – 2% Lidocaine (10mL); 1 – 11ga x 4" Bone Marrow Needle "J" Type; 1 – T-Lok Extraction Cannula; 1 – CSR Wrap***Catalog Number: CB0355TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | TLok Bone Marrow Tray – Angiotech***TLok Bone Marrow Tray***1 – #11 Mini Scalpel; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – Specimen Label; 1 – Stirring Rod; 1 – 8ga x 4 Bone Marrow Needed J Type; 1 16ga x 2.688 Bone Marrow Needle I Type; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 10 – Micro Slides – Frosted end; 1 – Fenestrated Drape; 1 – 1% Lidocaine (5mL); 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 – 4mL Specimen Tube w/EDTA; 1 – Probe Guide; 1 – Obturator; 1- Male Luer Cap; 1 T-Lok Extraction Cannula; 1 – Towel; 1 – 2"x3" ADH Dressing; 1 – 6/7 Dram Snap Cap Vials-Amber; 1 -Glass Slide Poly Bag; 1 – CSR Wrap***Catalog Number: BMT0804TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | T-Lok Ecomony Bone Marrow Tray – Angiotech***T-Lok Ecomony Bone Marrow Tray***1 – #11 Mini Scalpel; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – 11ga x 4" Bone Marrow Needle "J" Type; 1 16ga x 2.688" Bone Marrow Needle "I" Typ; 1 – 3" x 3" Sponges (4-Ply); 1 – Fenestrated Drape; 1 – 1% Lidocaine (5mL); 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 – Probe Guide; 1 – Obturator; 1 – Male Luer Cap; 1 – T-Lok Extraction Cannula; 1 – Towel; 1 – 2"x3" ADH Dressing; 1 – CSR Wrap; ***Catalog Number: BMET1104TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | T-Lok Ecomony Bone Marrow Tray – Angiotech***T-Lok Ecomony Bone Marrow Tray***1 – #11 Mini Scalpel; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – 11ga x 4" Bone Marrow Needle "J" Type; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – CSR Wrap; 1 – Fenestrated Drape; 1 – 1% Lidocaine (5mL); 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 – Towel; 1 – Probe Guide; 1 – Obturator; 1 – Male Luer Cap; 1 – T-Lok Extraction Cannula; 1 – 2"x3" ADH Dressing***Catalog Number: BMET1104ATL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | T-Lok Ecomony Bone Marrow Tray – Angiotech***T-Lok Ecomony Bone Marrow Tray***1 – #11 Mini Scalpel; 1 – 21ga x 1-1/2" Needle; 1 – 25ga x 5/8" Needle; 1 – 19ga x 1-1/2" Filter Needle; 1 – 5cc Syringe L/L; 1 – 20cc Syringe L/L; 1 – 8ga x 4" Bone Marrow Needle "J" Type; 1 – 16ga x 2.688" Bone Marrow Needle "I" Typ; 1 – 2"x3" ADH Dressing; 1 – Fenestrated Drape; 1 – 1% Lidocaine (5mL); 1 – 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 – Obturator; 1 – Male Luer Cap; 1 – Probe Guide; 1 – 3" x 3" Sponges in stacks of 5 (4-Ply); 1 – T-Lok Extraction Cannula; 1 – Towel; 1 – CSR Wrap ***Catalog Number: BMET0804TL***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.Intended for the purpose of harvesting bone and/or bone marrow specimens. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | HSG Procedure Tray 5Fr – Angiotech***HSG Procedure Tray 5Fr***1 – 18ga x 1-1/2" Needle; 1 – Fenestrated Drape; 1- 20cc Syringe L/L; 1 – Povidone-Iodine Ointment (1g); 2 – Povidone-Iodine Solution (1oz); 1 – Sanitary Napkin; 2 – Sponge Sticks (6"); 1 – Sound Dilator; 1 – Autobag; 1 – Lubricating Jelly; 2 – Cotton Tipped Swab (8"); 1 Extension Tubing (30"); 2 – 3"x3" Sponges (12-Ply); 1 – Vaginal Speculum; 1 – HSG Catheter (5Fr); 1 – Fixed Volume Syringe – 2cc; 1 – CSR Wrap (30"x30")***Catalog Number: 660005000***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Medical Device Technologies; Inc. | Nov-18-2011 | HSG Procedure Tray 7Fr – Angiotech***HSG Procedure Tray 7Fr***1 – 18ga x 1-1/2" Needle; 1 – Fenestrated Drape; 1- 20cc Syringe L/L; 1 – Povidone-Iodine Ointment (1g); 2 – Povidone-Iodine Solution (1oz); 1 – Sanitary Napkin; 2 – Sponge Sticks (6"); 1 – Sound Dilator; 1 – Autobag; 1 – Lubricating Jelly; 2 – Cotton Tipped Swab (8"); 1 Extension Tubing (30"); 2 – 3"x3" Sponges (12-Ply); 1 – Vaginal Speculum; 1 – HSG Catheter (7Fr); 1 – Fixed Volume Syringe – 3cc; 1 – CSR Wrap***Catalog Number: 660007000***Sterile – For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.MEDICAL DEVICE TECHNOLOGIES; INC. 3600 SW Ave. Gainesville; FL 32808 U.S.A. Domestic: 877-991-1110; International: 732-626-6466; customer_service@angio.com; www.angiotech.com.HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes. | Medical Device Technologies; Inc. dba Angiotech; is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14; 2010 for package integrity. |
| Cordis Corporation | Nov-17-2011 | SUPER TORQUE MB Angiographic Catheter – SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sideholes***SPECIAL***Angiographic Catheter*** REF Cat No.***Lot***Use By***Sterile EO***Assembled in Mexico Cordis Corporation; 14201 NW 60th Ave. Miami Lakes; Florida 33014; USA***EC***REP*** Cordis Cashel; Cahir Road Cashel; Co Tipperary; Ireland***Cordis***a Johnson&Johnson company***"UPN SRD5724MB; No MB 2; Length; cm 100; Sideholes 2.UPN SRD5727MB; No MB 4; Length; cm 80; Sideholes 4.Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system. | Cordis Corporation is issuing a Correction for their SUPER TORQUE MB Angiographic Catheter after receiving a report of marker bands dislodged during a procedure. Model Numbers 532598A; 532598B; 532598C; 532598D; SRD5724MB and SRD5727MB are affected by the Cordis Correction. |
| Cordis Corporation | Nov-17-2011 | SUPER TORQUE MB Angiographic Catheter – SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot***Use By***Assembled in Mexico Cordis Corporation; 14201 NW 60th Ave. Miami Lakes; Florida 33014; USA***EC***REP*** Cordis Cashel; Cahir Road Cashel; Co Tipperary; Ireland***Cordis***a Johnson&Johnson company***"UPN H739532598A3; Cat No 532-598A; No. MB 10; French Size 5; Shape (PIG); Length cm 110; Flow Rate; ml/sec; 18; Sideholes 6. UPN H739532598B3; Cat No 532-598B; No. MB 20; French Size 5; Shape (PIG); Length cm 110; Flow Rate; ml/sec; 18; Sideholes 6. UPN H73953298C3; Cat No 532-598C; No MB 20 French Size 5; Shape (PIG); Length; cm 65; Flow Rate; ml/sec; 30; Side Holes 6.UPN H73953298D3; Cat No 532-598D; No MB 2 French Size 5; Shape (PIG); Length ; cm 70; Flow Rate; ml/sec; 30; Side Holes 10.Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system. | Cordis Corporation is issuing a Correction for their SUPER TORQUE MB Angiographic Catheter after receiving a report of marker bands dislodged during a procedure. Model Numbers 532598A; 532598B; 532598C; 532598D; SRD5724MB and SRD5727MB are affected by the Cordis Correction. |
| Meridian Bioscience Inc | Nov-17-2011 | Premier EHEC Kit – EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4-Substrate II 12.5ml Lot# 1601EXP.5-Stop-Solution II 10.0 ml Lot# 1601EXP.6-EHEC Positive Control 3.4 ml Lot# 8601EXP.7-EHEC Negative Control 3.4 ml Lot# 1603EXP.8-96 transfer pipettes-1 Microwell holder-3 Microwell strip sealersThe Premier EHEC test kit is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II ( verotoxins) in stool specimens; broth cultures; from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. Coli (EHEC) infections. | Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested; however; the rate of occurrence will likely impact clinical sensitivity as defined by product registration and associated instructions for use. |
| Medtronic Minimed | Nov-17-2011 | Medtronic MiniMed paradigm mio Infusion Sets – Medtronic MiniMed paradigm mio Infusion Sets MMT-921The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum. | The consignee received four (4) boxes of mio infusion sets (MMT-921) that were shipped to them in error. These infusion sets were shipped in a package that included a MiniMed Paradigm REAL-TIME Insulin Pump among other items.The mio infusion sets were not authorized to be shipped to the consignee based on Medtronics internal product handling procedures and they may not function properly.T |
| SCC Soft Computer | Nov-17-2011 | SoftPath GUI – SoftPath GUI versions: 3.17.5 to 3.17.9; 4.2.1 to 4.2.3; and 4.3.0 to 4.3.0.4. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable; trained; and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical; gynecological; medical cytological; and autopsy case specimens within the Pathology labs; for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. | Soft Computer; Clearwater; FL; initiated a correction on the following SoftPath GUI versions: 3.17.5 to 3.17.9; 4.2.1 to 4.2.3; and 4.3.0 to 4.3.0.4. SoftPath architecture does not correctly handle AP macros and data fields inside report sections that are stored in the database. Improper information can be displayed in all places where the diagnosis from the database is read and displayed. |
| Lifewatch Services Inc | Nov-17-2011 | LifeStar ACT III Platinum Sensor – LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel EKG; office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Manufactured by Card Guard; 2 Pekeris St; Rehovot; 76100; Israel; Model FG-00084LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. The ACT III will provide more sensitive data for initial or early detection of arrhythmia in patients that have minimal or atypical symptoms. | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| Lifewatch Services Inc | Nov-17-2011 | LifeStar ACT I Sensor – LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel EKG; office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Manufactured by Card Guard; 2 Pekeris St; Rehovot; 76100; Israel; Model FG-00065LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| Lifewatch Services Inc | Nov-17-2011 | ACT Cellular Phone Monitor – ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG; office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Manufactured by Card Guard; 2 Pekeris St; Rehovot; 76100; Israel; there are two models used with either the ACT 1 sensor or the ACT III sensor:a) Model Ozone-HTCb) Model BlackJack2 SGH-i617LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| Physio Control; Inc. | Nov-16-2011 | LIFEPAK 20 defibrillator – The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings.Affected Product Part Numbers: 3202487-000 thru -012; 3202487-014 thru -027; 3203487-029 thru -039; 3202488-000 thru -019; U3202487-000; U3202487-015; U3202488-000. | When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable; the test plug signal can be misinterpreted as a patient waveform. |
| Stryker Howmedica Osteonics Corp. | Nov-16-2011 | Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; – Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah; NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex FranceThe MDM Liner and X3 Acetabular Inserts is a sterile single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica osteonics 22.2 mm and 28 mm diameter femoral heads. | Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used. |
| Stryker Howmedica Osteonics Corp. | Nov-16-2011 | Restoration ADM System X3 Acetabular Insert – Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah; NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex FranceThe Restoration ADM System X# Acetabular Insert is a sterile; single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28mm diameter femoral heads. | Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used. |
| Stryker Howmedica Osteonics Corp. | Nov-16-2011 | Restoration ADM System – Stryker Restoration ADM System Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah; NJ 07430 Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex FranceThe Restoration ADM is a sterile; single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads. | Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used. |
| Abbott Laboratories; Inc | Nov-16-2011 | Abbott Clinical Chemistry Urea Nitrogen – Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum; plasma; and urine. | The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species. |
| Caridian BCT; Incorporated | Nov-16-2011 | Spectra Optia Apheresis System – Spectra Optia Apheresis System; REF: 61000; Caridian BCT; Lakewood; CO 80215.A blood component separator used for therapeutic plasma exchanges. | Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis. |
| Stryker Instruments Div. of Stryker Corporation | Nov-16-2011 | Stryker – IBO Blade; Right; for use with Stryker TPS Reciprocating Saw; REF 5100-37-901; Stryker Instruments; Kalamazoo; MI.Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed; additional surgery to remove a broken blade; infection due to an unretrieved device component; complications associated with increased time under anesthesia to retrieve a broken blade; osteomyeli |
| Stryker Instruments Div. of Stryker Corporation | Nov-16-2011 | Stryker – IBO Blade; Left; for use with Stryker TPS Reciprocating Saw; REF 5100-37-902; Stryker Instruments; Kalamazoo; MI.Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed; additional surgery to remove a broken blade; infection due to an unretrieved device component; complications associated with increased time under anesthesia to retrieve a broken blade; osteomyeli |
| Stryker Instruments Div. of Stryker Corporation | Nov-16-2011 | Stryker – Right/Left IBO Blade Set; for use with Stryker TPS Reciprocating Saw; REF 5100-37-903; Stryker Instruments; Kalamazoo; MI.Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed; additional surgery to remove a broken blade; infection due to an unretrieved device component; complications associated with increased time under anesthesia to retrieve a broken blade; osteomyeli |
| Stryker Instruments Div. of Stryker Corporation | Nov-16-2011 | Stryker – Right IBO Blade ; for use with Stryker TPS Reciprocating Saw; REF 5100-37-901S2; Stryker Instruments; Kalamazoo; MI.Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed; additional surgery to remove a broken blade; infection due to an unretrieved device component; complications associated with increased time under anesthesia to retrieve a broken blade; osteomyeli |
| Stryker Instruments Div. of Stryker Corporation | Nov-16-2011 | Stryker – Left IBO Blade ; for use with Stryker TPS or Core Reciprocating Saw; REF 5100-37-902S2; Stryker Instruments; Kalamazoo; MI.Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus. | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed; additional surgery to remove a broken blade; infection due to an unretrieved device component; complications associated with increased time under anesthesia to retrieve a broken blade; osteomyeli |
| Alere San Diego | Nov-16-2011 | PDI Alcohol Prep Pads packaged in the INRatio kit. – PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads; 100/box.Alcohol Prep Pads; packaged in the Alere INRatio¿ 2 PT/INR Home Monitoring Kit; or Hemosense INRatio¿ 2 Prothrombin Time/INR Testing Kit; Self-Test System; Alcohol Prep Pads; packaged in the Hemosense INRatio¿ Prothrombin Time/INR Testing Kit; Self-Test System;Alcohol Prep Pads; packaged in the INRatio Starter Kit ProductModel Number: 0200086; 0200432; 0100007; 0100072The Alere INRatio¿2 PT/INR Home Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh; capillary whole blood. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio¿2 PT/ INR Home Monitoring System is not intended to be used for screening purposes. The Alere INRatio¿2 PT/INR Home Monitoring System should only be used with a prescription from your physician. The INRatio2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh; capillary whole blood. The INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio2 PT Monitoring System is not intended to be used for screening purposes. The INRatio2 PT Monitoring system should only be used with a prescription from your physician. The INRatio¿ system performs Prothrombin Time (PT) testing on fresh; capillary whole blood. The PT test is the principle assay used to monitor warfarin therapy. Patients taking warfarin and other oral anticoagulants should consult with their healthcare provider before adjusting their dosage. The thromboplastins used in performing PT tests can vary substantially causing differences in results between methods. The International Normalized Ratio (INR) is a mathematical correction of the PT result that adjusts for differences in thromboplastins. Consult your physician for the appropriate therapeutic range for you. | Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus. |
| Greiner Bio-One North America; Inc. | Nov-14-2011 | Vacuette 4ml EDTA DK2 tube – Greiner bio-one; 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209. | Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills. |
| Albahealth LLC | Nov-14-2011 | Pulstar(R) DVT PREVENTION SYSTEM – Pulstar(R) DVT PREVENTION SYSTEM; Anti-Embolism Wrap System; albahealth(R); A Subsidiary of Encompass Group; LLC.Prevention of DVT. | The wrap portion of the device was tearing at the seam. |
| Kerr/pentron Dba Kerr Corporation And Pentron Clinical | Nov-14-2011 | Breeze Self-Adhesive Resin Cement – Breeze Self-Adhesive Resin Cement; Part Number: N97A;Product Usage: The intended use of this device is for cementation of porcelain; resin; and metalbased inlays; onlays; crowns; bridges and posts. The material is not recommended for use on veneer restorations. | Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product. |
| Invacare Corporation | Nov-14-2011 | Invacare bariatric bed – Invacare 600 lb. Bariatric Bed; Head motor extension cable used on component numbers BAR5490 and BAR5490IVC. These components are part of the following Bed Model Number(s): BAR600; BARPKGCA; BAR600IVC; BARPKGIVC-1633; and BARPKG. | Invacare Corporation decided to recall the products because risk analysis reveals that miskeying or disconnection of the head motor extension cable during bed set-up may result in product damage; or in rare instances; the potential for fire. |
| Philips Medical Systems | Nov-10-2011 | Extended Brilliance Workstation-NM (EBW-NM) – Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P; 1.1.1A; 1.5H; 1.5.1A and 2.0Q -Field Test PeriodA nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data. | A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur. |
| Abbott Point Of Care Inc. | Nov-10-2011 | – i-Stat cTnI cartridgesIs an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. | i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed results. |
| LifeCell Corporation | Nov-09-2011 | Strattice Reconstructive Tissue Matrix for Stoma Reinforcement – LifeCell Strattice Reconstructive Tissue Matrix for Stoma ReinforcementCatalog #0606008 (6 x 6 cm); 0808008 (8 cm x 8 cm); (0610008 ( 6 cm x 10 cm).Intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. | The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product’s cleared indications for use in the US market. |
| Greiner Bio-One North America; Inc. | Nov-09-2011 | Quick Shield with Snappy Safety Holder – Quick Shield with Snappy Safety Holder; Greiner bio-one.The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions. | Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub. |
| Varian Medical Systems; Inc. Oncology Systems | Nov-09-2011 | Clinac; Trilogy; Trilogy Tx and Novalis linear accelerators – Varian Clinac; Trilogy; Trilogy Tx and Novalis linear accelerators.Manufactured by Varian Medical System; Palo Alto; CA.Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions; tumors and conditions anywhere in the body where radiation treatment is indicated. | Varian has received reports in which a user has remotely rotated the gantry into contact with the couch or with the patient; in both the manual mode and the automate mode. |
| Capintec Inc | Nov-09-2011 | Capintec CRC 25 PET – Capintec CRC 25 PET; item number 5130-3217 with Software Revisions 2.01 and 2.02PET dose calibrator | Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET |
| Stryker Spine | Nov-08-2011 | Mantis Rod Inserter – Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot – 33610 – Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale; NJ 07401-1677 USA Stryker Mantis Rod Inserter Inner Shaft Manufactured by: Stryker Spine SAS Z. I. Marticot – 33610 – Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale; NJ 07401-1677 USA IS2097MAN Mantis Rod Inserter ShaftUsed to facilitate insertion and delivery of a Mantis rod. | There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter. |
| Biomet 3i; LLC | Nov-08-2011 | OSSEOTITE Certain Implant – ***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park; Ed; 1; Planta 1 Pl. de la Pau s/n 08940 Cornella de Llobregat (Barcelona) Spain***Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. The Thread form titanium screws (cylindrical dental implants) designed to be placed into mandibular or maxillary jaws in order to affix a dental prosthesis (edentulous or partially edentulous segments) that replaces 1 or more missing teeth. | The product may contain a manufacturing defect; that if present; may prevent the driver; cover screw or abutment from fully engaging the implant. |
| Cardinal Health | Nov-07-2011 | 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 for which Cardinal Health has been unable to confirm the manufacturer’s compliance with section 502(o) of the FD&C Act: a) Adhesive Remover Wipes; component 050-0415; b) Perineze Perineal Witch Hazel Pad; component 505040Ac) 24" Infant Tape Measure; component 30942P; d) Triple Dye Drug; 10 unit dose; component PM1022; 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. | Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturers do not have all necessary FDA registrations or filings needed for these components. |
| Cardinal Health | Nov-07-2011 | 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 for which Cardinal Health has been unable to confirm the manufacturer’s compliance with section 502(o) of the FD&C Act: a) 24" Infant Tape Measure; component 30942P; b) Silicone Tubing; component SFM3-4450; c) Triple Dye Drug; 10 unit dose; component PM1022; d) Assembly Swabstick; component PS004; e) 18×26 Poly Lined Towel; component 8580Z; f) Disposable Vein Stripper; component 63-0431;g) Cotton Glove; Large; White; PR; NS; component 1051; h) Cotton Glove; Medium; White; PR; NS; component 1051M; i) 6 Inch Metric-Inch Ruler; component 18C-Thru; 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. | Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturers do not have all necessary FDA registrations or filings needed for these components. |
| Baxter Healthcare Renal Div | Nov-07-2011 | Baxter System 1000 Tina Hemodialysis Instrument – Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation; Renal Division; McGaw Park; IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis | The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test. |
| Becton Dickinson & Company | Nov-07-2011 | Becton Dickinson 1.0mL 28 G x 1/2" blister packaged insulin syringe – 1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920Intended use: Subcutaneous injection of insulin. | Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes. |
| Biopro; Inc. | Nov-04-2011 | BioPro Femoral Head 28 mm -6 mm – BioPro Femoral Head 28 mm -6 mm; Item 19003.Orthopedic femoral head for implantation. | BioPro Femoral Head Outer Packaging was found lacking proper seal ;compromising sterility. |
| Biopro; Inc. | Nov-04-2011 | BioPro Femoral Head 28 mm +18 – BioPro Femoral Head 28 mm +18; Item 19010.Orthopedic femoral head for implantation | BioPro Femoral Head Outer Packaging was found lacking proper seal ;compromising sterility. |
| AMO Manufacturing USA; LLC | Nov-04-2011 | INTRALASE FS Laser – Abbott brand IntraLase Femtosecond Laser System; Model 2; Catalog Numbers: 20003D/J/K; R20003D/J/K; 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA; LLC; Milpitas; CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK. | The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 ?m or deeper) created using the Laser System. |
| AMO Manufacturing USA; LLC | Nov-04-2011 | INTRALASE FS Laser – Abbott brand IntraLase Femtosecond Laser System; Model 3; Catalog Numbers: 20004D/J/K; R20004J/K; Product is manufactured and distributed by AMO Manufacturing USA; LLC; Milpitas; CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK. | The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 ?m or deeper) created using the Laser System. |
| AMO Manufacturing USA; LLC | Nov-04-2011 | INTRALASE FS Laser – Abbott brand Advanced Femtosecond Laser Systems; Model iFS; Catalog Number: J20007D/J/K;Product is manufactured and distributed by AMO Manufacturing USA; LLC; Milpitas; CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK. | The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 ?m or deeper) created using the Laser System. |
| Abbott Laboratories | Nov-04-2011 | ARCHITECT Cyclosporine – ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories; Diagnostics Division; Abbott Park; IL 60064 USA; list 1L75-25.The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart; liver and kidney transplant patients receiving cyclosporine therapy. | The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision. |
| Synthes USA (HQ); Inc. | Nov-04-2011 | Synthes Spine T-PAL Spacer System. – Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system.Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. | LABELING CORRECTION for Medical Device – previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated for use with autograft material. All accounts with record of receiving T-PAL Implant will receive notification of the labeling correction and a copy of the updated brochure. All |
| Ameditech Inc | Nov-03-2011 | Us Diagnostic ProScreen Drugs of Abuse Cup – ProScreen PSCup-5M Waived; Catalog Number: PSCup-5M WaivedProduct Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual; qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagnostic and treatment purposes; consult with a healthcare or substance abuse professional. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result; particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result; a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method. | The recall was initiated because Ameditech; Inc. received a complaint from US Diagnostics (USD) that First Check Drug Screen Cups were packaged in the ProScreen Cup boxes. Some of US Diagnostics’ customers received ProScreen 5-panel cups that contain First Check THC cups. The recalled products are mislabeled. If the USD customer receives the FirstCheck tes; there will be no instructions for use |
| Biomet 3i; LLC | Nov-03-2011 | Conical Abutment Cylinder – "***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1’***".Attach an implant to an implant restoration. | On 09/28/2011 Biomet 3i; Palm Beach Gardens; FL initiated a recall of their Conical Angled Abutment; Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478. The packaging for the referenced products may not have been completely sealed prior to shipment. |
| Biomet 3i; LLC | Nov-03-2011 | Conical Angled Abutment – "***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF AC4425***Conical 25 ANGLED ABUTMENT***4.1mm(D) X 4mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1’***".Attach an implant to an implant restoration. | On 09/28/2011 Biomet 3i; Palm Beach Gardens; FL initiated a recall of their Conical Angled Abutment; Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478. The packaging for the referenced products may not have been completely sealed prior to shipment. |
| Encore Medical; Lp | Nov-02-2011 | RSP Baseplate Rim Planer (Size 32; 36; 40) – RSP Baseplate Rim Planer (Size 32; 36; 40):DJO Surgical Instruments and Instrument CasesDJO surgicalEncore Medical; L.P. 9800 Metric Blvd; Austin; TX 78758Contact information: DJO Surgical; ATTN: Customer Service; 9800 Metric Blvd; Austin; TX 78758; 1-800-456-8696The Baseplate Rim Planer is used to prepare the bone around the peripheral rim of the reamed socket. It has a spring loaded alignment pin on the proximal (cutting) end used in both alignment of the planer and as an indication that the planer has been seated fully. | DJO Surgical has determined that the alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU. |
| Encore Medical; Lp | Nov-02-2011 | RSP Humeral Socket Reamer (Size 32 SML) – RSP Humeral Socket Reamer (Size 32 SML):DJO Surgical Instruments and Instrument CasesDJO surgicalEncore Medical; L.P. 9800 Metric Blvd; Austin; TX 78758Contact information: DJO Surgical; ATTN: Customer Service; 9800 Metric Blvd; Austin; TX 78758; 1-800-456-8696.The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully. | DJO Surgical has determined that the alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU. |
| Medtronic Inc. Cardiac Rhythm Disease Management | Nov-02-2011 | Medtronic CryoCath Arctic Front CryoAblation Catheter – Medtronic Arctic Front Catheter; Sterile EO; Medtronic CryoCath LP; Kirkland; Quebec; H9H 5 H3; Canada; Model 2AF282 and 2AF231 ( not distributed in US)Product Usage: The Medtronic CryoCath System consists of a Cryoablation console; cardiac Cryoablation catheters; connection components and accessories. The Arctic Front Cardiac Cryoablation Catheter is an over the wire Balloon catheter. The inside of the Balloon at the distal end of the Cryoablation Catheter reaches temperatures of -50¿C or colder when refrigerant is injected from the console to the inside of the balloon. Arctic Front Cardiac Cryoablation catheters are introduced into the vasculature by traditional minimally invasive techniques. The CryoConsole houses the electrical and mechanical components as well as proprietary software for controlling and recording a cryotherapy procedure with Arctic Front and/or the Freezor family of catheters. It stores and controls the delivery of the liquid refrigerant through the coaxial umbilical to the catheter; recovers the refrigerant vapor from the catheter under constant vacuum; and disposes of the refrigerant through the hospital scavenging system. Multiple features are built into the catheter and the CryoConsole system to ensure safety. | Medtronic CryoCath has identified specific lots of Arctic Front CryoAblation Catheters that were distributedwith incorrect programming that may result in false expired catheter notifications. Impacted lots are 21571;25375; 25376; 25377; and 25381 of the Arctic Front Catheter Model Number 2AF282. Medtronic CryoCathis communicating this information to the FDA.On affected catheters; the incor |
| Medrad Inc | Nov-02-2011 | Medrad(R) Sterile Disposable Stellant Syringe Kit – Medrad(R) Sterile Disposable Stellant Syringe Kit; Catalog # SDS-CTP-SPK; Lot # 112865.Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy. | Packaging may exhibit open seals – sterility compromised |
| Merz Aesthetics; Inc. | Nov-01-2011 | Radiesse – MERZ AESTHETICS; Radiesse¿ Volume Advantage 1.5 CC; Injectable Implant; Part Number 8071M0H1 and 8071M0K1; Sterile; Rx ONLY.Part Number 8071M4K1 distributed in CanadaPart Number 8071M5 distributed in Europe/Middle East/AfricaPart Number 8071M9 distributed in Hong Kong; Korea; Malaysia. | There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe; Health Care Professionals should be alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent impairment or damage. To date Merz has n |
| Mako Surgical Corporation | Nov-01-2011 | RIO Robot Arm Interactive Orthopedic System – Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM; 201251 RIO GUIDANCE MODULE; 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9.6/8.0/4.2 Hz 50/60 Class I Equipment. Conforms to IEC 60601-1/A2: 1995; EN 60601-1/A2: 1995 UL 60601-1: 2003; CAN/CSA-C22.2 No. 601.1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 DAVIE ROAD; FT. LAUDERDALE; FL 33317.RIO System – The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Tactile Guidance System v2.0 is indicated for use in surgical knee procedures; in which the use of stereotactic surgery may be approriate; and where reference to rigid anatomical bony structures can be identified relative to a CT base model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement. | MAKO Surgical Corp. is recalling their RIO Robotic Arm Interactive Orthopedic System (RIO) due to software issue that exist that could potentially result in a bone resection. No adverse events reported. |
| Davol; Inc.; Sub. C. R. Bard; Inc. | Nov-01-2011 | Bard¿ Ventralex" ST Medium Circle with Strap Hernia Patch – Bard¿ Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5"; Catalog Number: 5950008.Intended for use in the reconstruction of soft tissue; where weakness exists; in procedures involving soft tissue repair; including repair hernias and deficiencies caused by trocars. | Mislabeled: Bard? Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard?Ventralex" ST Large Circle. |
| Bioplate Inc | Nov-01-2011 | Bioplate Titanium Fixation System; Sterile Kit. – Bioplate Titanium Fixation System; Sterile Kit.The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation; including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant. | There is potential defect in seal of the sterile barrier containing the device. |
