Class I recalls
Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
Cardiac Science Corporation | Feb-27-2012 | Powerheart AED; CardioVive AED; GE Responder AED; Nihon Kohden CardioLife AED – Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A; 9300E; 9300P; 9390A; 9390E; CardioVive 92532; 92533; Nihon-Kohden 9200G; 9231; and GE Responder 2019198; 2023440 AEDs.The Powerheart AED G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation; if the victim is breathing; the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs; the device will charge automatically and be able to deliver therapy. The device is intended to be used by personnel who have been trained it is operation. The user should be qualified by training in basic life support or other physician-authorized medical response. | The affected Automated External Defibrillators (AEDs) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt; the AED may not deliver defibrillation therapy. |
Flight Medical Ltd. | Feb-21-2012 | V24-00400-29 cable – V24-00400-29 cable; an accessory to the Newport HT50 ventilator.The V24-00400-29 cable is an accessory to the Newport HT50 ventilator intended to transfer the alarm signal from the ventilator to a nurse remote station. | The recall was initiated because Flight Medical Innovations Ltd. has identified a problem may occur when contact between an exposed unused wire and the grounding wire occurs. If this contact occurs the ventilator may reset and switch off. |
Nemschoff Chairs; Inc. | Feb-01-2012 | Bassinet – Bassinet Models: BSNT/01; BSNT/02; BSNT/03; BSNT/04The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient. | To correct issues with casters; door hinges; drawer slides; and the bassinet surround. Also; to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits. |
Class II recalls
Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
Kerr Corporation | Feb-28-2012 | Fusio Liquid Dentin – Brand Name: Fusio Liquid Dentin; part number N21SB; N21SC.Product Usage:The intended use of this device is as a self-etch; self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include self-etch base liner; restorations of carious lesions; Class I; III and V cavity preparations and pitt and fissure sealant. | A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected. |
PerkinElmer Life and Analytical Sciences; Wallac; OY | Feb-28-2012 | Perkin Elmer – Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. | GSP instruments with defective washer modules may cause a false negative screening result being reported for T4; TSH and IRT. For 17-OHP; a false positive result may be generated if the failure occurs for a normal sample. |
Angiodynamics Worldwide Headquarters | Feb-28-2012 | BENEPHIT CV Infusion System – AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System — Catalog No. [REF] 60035 — Manufactured in USA — [Mfg symbol] AngioDyanamics; 603 Queensbury Avenue; Queensbury; NY USA 12804.Intended to facilitate targeted renal therapy; or TRT; the delivery of physician-specific agents to the kidneys via the renal arteries. | The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks. |
Angiodynamics Worldwide Headquarters | Feb-28-2012 | BENEPHIT CV Infusion System – AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System — Catalog No. [REF] 60030 — Manufactured in USA — [Mfg symbol] AngioDyanamics; 603 Queensbury Avenue; Queensbury; NY USA 12804.Intended to facilitate targeted renal therapy; or TRT; the delivery of physician-specific agents to the kidneys via the renal arteries. | The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks. |
Angiodynamics Worldwide Headquarters | Feb-28-2012 | BENEPHIT CV Infusion System – AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System — Catalog No. [REF] 60040 — Manufactured in USA — [Mfg symbol] AngioDyanamics; 603 Queensbury Avenue; Queensbury; NY USA 12804.Intended to facilitate targeted renal therapy; or TRT; the delivery of physician-specific agents to the kidneys via the renal arteries. | The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks. |
Ortho-Clinical Diagnostics | Feb-28-2012 | VITROS¿ Chemistry Products PHBR Slides – VITROS¿ Chemistry Products PHBR Slides; REF 822 1384 — COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides — Ortho-Clinical Diagnostics; Inc. Rochester; NY — Ortho-Clinical Diagnostics High Wycombe; UK — This is an in vitro diagnostic. For in vitro diagnostic use only. VITROS¿ Chemistry Products PHBR Slides quantitatively measure Phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950 and 5;1 FS Chemistry Systems and the VITROS 5600 Integrated System. | Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision; outliers; or shifts in control fluid values when using various lots of VITROS? Chemistry Products PHBR Slides (Phenobarbital) from Coating 0053. |
GE Healthcare; LLC | Feb-27-2012 | GE Discovery NM/CT 670 – GE Discovery NM/CT 670The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting; localizing; diagnosing of diseases and organ function for the evaluation of diseases; trauma; abnormalities; and disorders such as; but not limited to; cardiovascular disease; neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; planning; guiding; and monitoring therapy. The GE Discovery NM/CT 670 system; combining Nuclear Medicine (NM) and Computed Tomography (CT) systems; is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. | GE Healthcare has recently become aware of a potential safety issue associated with the collimator cart and lead cover of your Discovery NM/CT 670 and/or Discovery NM 630 system that may impact operator safety. 1. The cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury.2. Another issue is that the |
GE Healthcare; LLC | Feb-27-2012 | GE Discovery NM 630 – GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting; localizing; diagnosing of diseases and in assessment of organ function for the evaluation of diseases; trauma; abnormalities; and disorders such as; but not limited to; cardiovascular disease; neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; planning; guiding; and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system; which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body; using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. | GE Healthcare has recently become aware of a potential safety issue associated with the collimator cart and lead cover of your Discovery NM/CT 670 and/or Discovery NM 630 system that may impact operator safety. 1. The cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury.2. Another issue is that the |
Becton Dickinson & Co. | Feb-27-2012 | BBL [TM] LYSINE IRON AGAR – BBL[TM] Lysine Iron Agar; catalog #211363;500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton; Dickinson and Company; Sparks; MD 21152 USA 38800 Le Pont de Claix; France.Lysine Iron Agar was developed for the use for differentiation of enteric organisms; in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide. | Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product.. |
Becton Dickinson & Co. | Feb-27-2012 | BBL [TM] LYSINE IRON AGAR – BBL[TM] Lysine Iron Agar; catalog #211363;500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton; Dickinson and Company; Sparks; MD 21152 USA 38800 Le Pont de Claix; France.Lysine Iron Agar was developed for the use for differentiation of enteric organisms; in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide. | Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product.. |
Becton Dickinson & Co. | Feb-27-2012 | BBL [TM] LYSINE IRON AGAR – BBL[TM] Lysine Iron Agar; catalog #211363;500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton; Dickinson and Company; Sparks; MD 21152 USA 38800 Le Pont de Claix; France.Lysine Iron Agar was developed for the use for differentiation of enteric organisms; in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide. | Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product.. |
Winco Mfg.; LLC | Feb-26-2012 | Premier Care Recliner Model 5570 – Premier Care Recliner Model 5570. Brochure: "***Premier Care Recliner 5570/5574***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Multiple side-table options***3-position lock-bar*** Fully upholstered***OPTIONAL Heat or Heat & Massage***OPTIONAL LiquiCell***1.800.237.3377***5516 SW 1st Lane***Ocala; Florida 34474***www.wincomfg.com***Proudly Made in the USA.***"Press on type label: "***Manufactured By Winco Ocala; FL 34474***Model No. 557***Serial No. 557-…***"Press on type label: "***Model No. 557***Serial No.557-…***".Long-term multi-positional recliner. | On 10/17/2011 Winco Mfg. LLC; Ocala; FL initiated a recall of The Premier LifeCare Recliner and Premier Care Recliner Models 5400 and 5570 distributed between January 4; 2011 and October 12; 2011. The Position Lock Pin(s) could potentially fail if exposed to excessive force when the chair is in the Locked Recline position. This failure will result in an inoperable Position Lock Bar feature. |
Winco Mfg.; LLC | Feb-26-2012 | Premier LifeCare Recliner 5400 – Premier LifeCare Recliner 5400. Brochure is labeled in part: "***Premier LifeCare Recliner 5400***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Fully upholstered***Multiple side-table Options***3-position lockbar*** "No pinch" safety zone***1.800.237.3377***5516 SW 1st Lane***Ocala; Florida 34474***www.wincomfg.com***Proudly Made in the USA.***"Press on type label: "***Manufactured By Winco Ocala; FL 34474***Model No. 540***Serial No. 540-…***"Press on type label: "***Model No. 557-…***Serial No.***".Long-term multi-positional recliner. | On 10/17/2011 Winco Mfg. LLC; Ocala; FL initiated a recall of The Premier LifeCare Recliner and Premier Care Recliner Models 5400 and 5570 distributed between January 4; 2011 and October 12; 2011. The Position Lock Pin(s) could potentially fail if exposed to excessive force when the chair is in the Locked Recline position. This failure will result in an inoperable Position Lock Bar feature. |
Kerr Corporation | Feb-24-2012 | Breeze Self-Adhesive Resin Cement – Breeze Self-Adhesive Resin Cement; part number: N97F. The intended use is for cementation of porcelain; resin; and metal-based inlays; onlays; crowns; bridges; and posts. | The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material; it could possibly result in inadequate bond strength. |
Mindray DS USA; Inc. d.b.a. Mindray North America | Feb-24-2012 | V Series Monitor – V Series MonitorMindray DS USA; Inc.800 MacArthur Boulevard.Mahwah; NJ 07430The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3; 5; 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac Output (CO) Respiratory Gasses Respiration Rate Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices | A system database corruption may occur that causes the V Series Monitor to reset. |
Capitol Vial Inc | Feb-24-2012 | Oral-Eze (R) Oral Fluid Collection System – Oral-Eze (R) Oral Fluid Collection System; manufactured by Capitol Vial; Inc.; Auburn; AL 36832Product Usage:IVD for drugs of abuse | Low buffer fill volumes on Oral-Eze; an oral fluid collection system. |
Sunrise Medical (US) LLC | Feb-24-2012 | Zippie TS wheelchair – Sunrise Medical Zippie TS wheelchairTo empower physically challenged person by providing a means or mobility. | One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle; however the chair was not configured with a back tested seat for motor vehicle use. |
Clarity Medical Systems Inc | Feb-24-2012 | Retcam3 & Retcam Shuttle with version – Retcam3 & Retcam Shuttle with version 6.0 software.Clarity Medical Systems; Inc.5775 W. Las Positas Blvd; Suite 200Pleasanton; CA 94588General ophthalmic imaging including retinal; corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP. | Still images extracted from video recordings may be mislabeled as to right and left eye. |
Cardinal Health | Feb-24-2012 | Presource Custom Sterile Surgical and Procedure Kits – Presource Custom Sterile Surgical and Procedure Kits containing Ethicon Ethilon Black Nylon Nonabsorbable Surgical Sutures in new Tyvek packaging; surgical trays; Cardinal Health; McGaw Park; IL 60085; 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 ethylene oxide sterilized and are ready to be used by the customer for the specific procedure. 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 ethylene oxide sterilized and are ready to be used by the customer for the specific procedure. | The Presource kits were assembled with Ethicon Sutures in new Tyvek packaging which could no longer be placed in kits that will undergo ethylene oxide sterilization. |
Varian Medical Systems; Inc. Oncology Systems | Feb-23-2012 | 52-leaf Millennium MLC multileaf collimator – Varian brand 52-leaf Millennium MLC multileaf collimator;Reference/FSCA Identifier: CP-04792; All models; including H52; H54; H56; HHM; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA.The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. | When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping; under specific treatment conditions; dose may be delivered outside of the intended treatment field that exceed the expected transmission dose. |
Siemens Medical Solutions USA; Inc | Feb-23-2012 | Syngo RT – ARTISTE; ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace; version 4.1. Manufactured by Siemens AG; Kemnath; Germany. The indication is to deliver X-ray; photon and electron radiation for the therapeutic treatment of cancer. | Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment. |
Varian Medical Systems; Inc. Oncology Systems | Feb-23-2012 | 52-leaf Standard MLC multileaf collimator – Varian brand Varian 52-leaf Standard MLC multileaf collimator;Reference/FSCA Identifier: CP-04792; Model Number(s): All models; includingH52; H54; H56; HHM; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA.The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. | When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping; under specific treatment conditions; dose may be delivered outside of the intended treatment field that exceed the expected transmission dose. |
ORIGIO HUMAGEN PIPETS INC. | Feb-23-2012 | Cryopette – ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456 2013-10-10 Exp. date *** MADE IN THE USA STERILE R ***Origio; Inc. 3400 Hunter’s Way; Charlottesville; VA 22911 www.origio.comThe Cryopette (r) is a cryopreservative storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos. | Cryopettes were rupturing during the warming process following vitrification. |
Accuray Incorporated | Feb-23-2012 | CyberKnife Robotic Radiosurgery System – CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System; versions 3.0; 3.1; 3.5.1; 3.5.2 and 3.5.3 with Ray-Tracing dose calculation.Accuray Incorporated; Sunnyvale; CA.Treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions; tumors and conditions anywhere in the body when radiation treatment is indicated. | An anomaly was discovered during internal regression testing; where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing dose calculation algorithm. As a result; it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery. |
GE Healthcare; LLC | Feb-23-2012 | LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM – GE Healthcare; LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM with R1.1.0 Software. Intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ; Peripheral Vascular; etc. | GE Healthcare has become aware of a potential safety issue where an image from a different patient; or an image from the current patient with title information from a different patient maybe noticed. |
Lab Vision Corporation | Feb-22-2012 | UltraVision Detection System; Anti-Polyvalent; Alk-Phos/Fast Red (Ready to Use) – UltraVision Detection System;Anti-Polyvalent; Alk-Phos/Fast Red (Ready to Use)Manufactured by: Lab Vision Corporation46360 Fremont Blvd; Fremont; CA 94538Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody; secondary antibody; and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. | Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher. |
Lab Vision Corporation | Feb-22-2012 | Streptavidin Alkaline Phosphatase (Ready to Use) – Streptavidin Alkaline Phosphatase (Ready to Use)Manufactured by: Lab Vision Corporation46360 Fremont Blvd; Fremont; CA 94538Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody; secondary antibody; and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. | Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher. |
Lab Vision Corporation | Feb-22-2012 | UltraVision Detection System; Anti-Rabbit; Alk-Phos/BCIP/NBT (Ready to Use) – UltraVision Detection System;Anti-Rabbit; Alk-Phos/BCIP/NBT (Ready to Use)Manufactured by: Lab Vision Corporation46360 Fremont Blvd; Fremont; CA 94538Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody; secondary antibody; and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. | Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher. |
Lab Vision Corporation | Feb-22-2012 | UltraVision Plus Large Volume Detection System; Anti-Polyvalent; Alk-Phos (Ready to Use) – UltraVision Plus Large Volume Detection System;Anti-Polyvalent; Alk-Phos (Ready to Use)Manufactured by: Lab Vision Corporation46360 Fremont Blvd; Fremont; CA 94538Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody; secondary antibody; and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. | Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher. |
Lab Vision Corporation | Feb-22-2012 | UltraVision Large Volume Detection System; Anti-Polyvalent; Alk-Phos (Ready to Use) – UltraVision Large Volume Detection System;Anti-Polyvalent; Alk-Phos (Ready to Use)Manufactured by: Lab Vision Corporation46360 Fremont Blvd; Fremont; CA 94538Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody; secondary antibody; and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. | Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher. |
Lab Vision Corporation | Feb-22-2012 | UltraVision Detection System; Anti-Polyvalent; Alk-Phos/BCIP/NBT (Ready to Use) – UltraVision Detection System;Anti-Polyvalent; Alk-Phos/BCIP/NBT (Ready to Use)Manufactured by: Lab Vision Corporation46360 Fremont Blvd; Fremont; CA 94538Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody; secondary antibody; and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. | Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher. |
Lab Vision Corporation | Feb-22-2012 | UltraVision Plus Detection System; Anti-Polyvalent; Alk-Phos/Fast Red (Ready to Use) – UltraVision Plus Detection System;Anti-Polyvalent; Alk-Phos/Fast Red (Ready to Use)Manufactured by: Lab Vision Corporation46360 Fremont Blvd; Fremont; CA 94538Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody; secondary antibody; and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. | Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher. |
Alere San Diego | Feb-22-2012 | Strep A Twist Rapid Test Cassette – Strep A Twist Rapid Test Cassette (K023766); IST-502T Twist Cassettes.Brand Name (Catalog Number): ACON Rapid Device Strep A Twist (IST-502T); CONSULT Diagnostics Strep A Twist; PSS (5005); Medi-Lab Performance Strep A Test-Twist; McKesson (32-502T); MooreBrand Strep A Twist Cassette; Moore (82793); and SP Strep A Rapid Twist Cassette Test; Cardinal Health (B1077-29).Type of Packaging (ie. box; plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50); the kits also include: disposable extraction test tubes; dropper tips; sterile swabs; 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite; 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid; 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3; 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box.The Strep A Rapid Test Cassette and Twist devices are qualitative; lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab; providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only. | Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12; 2011 to all lots of product that were on the market within the expiry period. |
Alere San Diego | Feb-22-2012 | Strep A Rapid Test Cassette – Strep A Rapid Test Cassette (K031784); IST-502 Cassettes.Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Rapid Test Device (IST-502); BD Directigen EZ Group A Strep; Becton Dickinson (256032); Clearview Strep A Exact II Cassette (920003); CONSULT Diagnostics Strep A Cassette; 25T; PSS (5004); CONSULT Diagnostics Strep A Cassette; 50T; PSS (5009); Detector Strep A Direct; Immunostics (IMMIL-Strep25); E-Z Well Strep A Test Device; 25T; StanBio (6100-025L); E-Z Well Strep A Test Device; 5T; StanBio (6100-05L); Henry Schein One Step + Strep A Cassette Test (9004051); Medi-Lab Performance Strep A Test-Cassette; McKesson (32-502); Poly stat Strep A Cassette Test; Polymedco (STC 20); Signify Strep A Cassette (1P47-40); and SP Brand Strep A Rapid Cassette Test; Cardinal Health (B1077-26). Type of Packaging (ie. box; plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50); the kits also include: disposable extraction test tubes; dropper tips; sterile swabs; 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite; 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid; 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3; 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box.The Strep A Rapid Test Cassette and Twist devices are qualitative; lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab; providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only. | Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12; 2011 to all lots of product that were on the market within the expiry period. |
Microsoft Corporation Health Solutions Group | Feb-22-2012 | Microsoft Amalga Unified Intelligence System – Microsoft Amalga – previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009Product Usage:Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate; store; display; and share disparate data either coming from many source systems or directly entered by end users for rapid self-service data exploration and analysis by front line managers; clinicians and ancillary staff. Furthermore; Amalga UIS allows healthcare providers to rapidly create new applications to respond to evolving business and clinical needs. | Healthcare providers reported that when sharing a single browser session on Amalga Web; patient A’s data can be displayed under patient B’s name. |
Corpak Med Systems | Feb-22-2012 | CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor – CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube;10 Fr; 36" (91 cm); 3 Gram weighted bolus; individually packaged; 5 tubes per case; CORPAK MedSystems; Wheeling; IL 60090; catalog/reorder #30-7361; For delivery of enteral nutritionProduct Usage: For delivery of enteral nutrition | The wrong size Twoomey adapter was packaged with the Jejunal tube. |
Greiner Bio-One North America; Inc. | Feb-22-2012 | LH Lithium Heparin tubes – LH Lithium Heparin tubes; Greiner bio-one; North America; 4238 Capital Drive; Monroe; NC 28110.Venous blood collection tubes. | The lithium heparin tubes may have a contamination with EDTA potassium. |
Angiodynamics Worldwide Headquarters | Feb-21-2012 | Morpheus Smart PICC – AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT — 5F Dual Lumen 65cm — Max CT Flow Rate: 4mL/sec — Kit Contains: — 1 each Nitinol Guidewire; 0.46mm (0.018in.) x 130cm — Catalog No. [REF] 52110901 — [Mfg symbol] AngioDynamics; Inc.; 603 Queensbury; NY USA 12804.Indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire. |
Angiodynamics Worldwide Headquarters | Feb-21-2012 | Morpheus Smart PICC – AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT — 4F Single Lumen 65cm — Max CT Flow Rate: 4mL/sec — Kit Contains: — 1 each Nitinol Guidewire; 0.46mm (0.018in.) x 130cm — Catalog No. [REF] 52110902 — [Mfg symbol] AngioDynamics; Inc.; 603 Queensbury; NY USA 12804.Indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. | The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire. |
Biomet; Inc. | Feb-21-2012 | Discovery Elbow System Humeral Condyle Set- Hexalobular – Discovery Elbow System Humeral Condyle Set- Hexalobular; REF 114700; Lot 797550 Alloy; Sterile; Biomet Orthopedics Warsaw IN 46581.Intended for primary and revision joint arthroplasty for use in cemented applications. | A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery; and was found to contain two male condyles. |
Elekta; Inc. | Feb-21-2012 | XVI R4.5 X-ray Volume Imaging System – Elekta Synergy XVI 4.5 and R4.6To be used as part of radiation therapy treatment process. | If a user; using an on-line correction protocol; clicks the accept correction button; an approval dialog box appears. If cancel is selected; the table correction values return to their initial values; but the image panes continue to display the changed position. |
GE Healthcare; LLC | Feb-21-2012 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS – REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESISThe Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use. | GE Healthcare has become aware of a potential issue associated with the hand grip that is clamped to the table top of your Revolution XRD X-ray systems that may impact patient safety. The hand grip accessory that is clamped to the table top may not be properly adjusted and can dislodge during use. Should this happen during patient loading or unloading; patient injury could occur. |
GE Healthcare; LLC | Feb-21-2012 | GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). – GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite).The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution; high signal-to-noise ratio; with short scan times. The Signa¿ Excite MR system with Surgical Option is indicated for use as a diagnostic imaging device to produce axial; sagittal; coronal and oblique images; spectroscopic images; and/or spectra; dynamic images of the internal structures and organs of the entire body; including; but not limited to; head; neck; TMJ; spine; breast; heart; abdomen; pelvis; joints; prostate; blood vessels; and musculoskeletal regions of the body. The images produced by the Signa" Excite system with Surgical Option reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The GE Signa" Excite system with Surgical Option can provide MR images at various stages of a surgical procedure; and provides the capability to transfer a patient to the MR system table directly from a surgical table; or patient transport system. Images can be obtained using the MR scanner body coil; or local surface coils; and the surface coils used with the integrated system may/can accommodate sterile draping for surgical procedures. | GE Healthcare has recently become aware of a potential safety issue due to the failure of the transfer board release lever associated with the OR Compatible patient transfer table of your Optima MR450w MR Surgical Suite. |
Siemens Medical Solutions USA; Inc | Feb-20-2012 | Siemens syngo Imaging XS – Siemens syngo Imaging XS. Radiological image processing system. | In September 2011 firm issued two Customer Safety Advisory Notices for syngo Imaging XS. Firm became aware of an unintended behavior when using syngo Imaging XS; version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using the thumbnails may cause unintended deletion of images/series. In response; firm issued a Customer Safety Advisor |
GE Healthcare; LLC | Feb-20-2012 | GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM – GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D).The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems. | GE Healthcare has become aware of inaccurate measurements on GE magnified images provided by Senographe 2000D Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety. |
Geomed Medizin-Technik Gmbh & Co. | Feb-19-2012 | ASSISTO – ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel tubular; articulated arms. Product Usage:ASSISTO Arm Systems with a holding power of up to 50N are designed as universal support systems for ventilator tubing and breathing tubes. When equipped with the appropriate accessories these arm systems may also be used to hold endoscopes. They are usually proved with non-insulated clamp sockets. All ASSISTO Arm Systems with a holding power of up to 100N are designed as universal support and holding systems for endoscope holders and detractors or other accessories. These systems are attached to the operating table with an electrically insulated clamp socket and are designed to hold the accessory in the desired position for a short period of time (which may exceed 60 minutes. | The product may fracture during surgical procedures. |
AGFA Corp. | Feb-19-2012 | DX-D Imaging Package – Agfa DX-D Imaging Package – (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems)Product Usage:DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull; spinal column and extremities); chest; abdomen and other body parts. The product is not indicated for use in mammography. | The firm received a complaint that when using the DX-D Mobile DR X-Ray unit they noticed the detector cable was hot. |
Leica Microsystems; Inc. | Feb-17-2012 | Leica Bond Ready-to-Use Primary Antibody CD2 (11F11) – Leica Bond Ready-to-Use Primary Antibody CD2 (11F11); 7 mL vial; an in vitro diagnostic primary antibody for use as part of an antibody panel for the characterization of T cell disorders; Catalog No. PA0271; Leica Biosystems Newcastle Ltd.; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom. For the qualitative identification by light microscopy of human CD2 molecule in formalin-fixed; paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. | The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated. |
Leica Microsystems; Inc. | Feb-17-2012 | Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent – Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent; an in vitro diagnostic primary antibody for use as part of an antibody panel for the classification of tumors of T-cell origin; Catalog No. NCL-L-CD7-580; packaged in 1 mL vials and 0.1 mL vials; Leica Biosystems Newcastle Ltd.; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom. NCL-L-CD7-580 is intended for the qualitative identification by light microscopy of CD7 molecules in paraffin-embedded tissue by immunohistochemical staining. | The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated. |
Leica Microsystems; Inc. | Feb-17-2012 | Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent – Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro diagnostic monoclonal antibody for use as part of an antibody panel for the classification of tumors of T-cell origin; Catalog No. PA0266; Leica Biosystems Newcastle Ltd.; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom. For the qualitative identification by light microscopy of CD7 molecule in formalin-fixed; paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. | The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated. |
Philips Medical Systems (Cleveland) Inc | Feb-17-2012 | TruFlight Select PET/CT Scanning System – TruFlight Select PET/CT System equipped with software version 3.5.3.10; Model #459800111661.A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. | A number of non-conformances have been noted in the TruFlight Select PET/CT System. A number of these non-conformances have been corrected to improve the overall quality and functionality of the suspect system units. |
Lucero Medical LLC | Feb-17-2012 | ENDURAMESH CORPECTOMY SPACER SYSTEM – ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM; 017MM; 023MM by varying heights. Dist. By: Lucero Medical; PO Box 67; Richfield; Ohio 44826Product Usage:Device Description: The Enduramesh is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy; aiding in spinal fusion. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference. The Enduramesh vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions. Various diameters and heights are available to accommodate variability among patients. Indications for Use: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed; damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autoograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference. | During an FDA inspection the firm was informed that the device marketed is not the device cleared for the 510K associated with the device. The product is sold unlabeled. |
Ascension Orthopedics; Inc | Feb-17-2012 | First Choice Partial Ulnar Head System ("DRUJ System"). – Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm; 16.0 mm; 17.5 mm; and 19.0 mm each with stem sizes 4.5 mm; 5.5 mm; or 6.5 mm.The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is indicated for replacement of the distal ulnar head for rheumatoid; degenerative; or post-traumatic arthritis | A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a submission of a filing with the FDA. |
GE Healthcare; LLC | Feb-17-2012 | GE eXplore Locus Micro CT. – GE eXplore Locus Micro CT cabinet x-ray system model RS9-80.CT Scanner for laboratory mice or other research. | Product fails to comply with the federal performance standard for cabinet x-ray systems (Title 21 CFR 1020.40(c)(1)(i)). Specifically; the x-ray emission limit of 0.5 milliroentgen in one hour could be exceed. Highest emission measured was 3 mR/hr. |
Philips Medical Systems (Cleveland) Inc | Feb-16-2012 | InGenuity CT System – Ingenuity CT (Computed Tomography) System; 510 (k) #K033326; Model #728326; Serial Numbers: 300003; 300004; 300005; and 300010. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-a¿sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Software defect. Philips learned of this device issue following their receipt of a customer complaint reporting that a ‘gap’ is created in the side covers when the gantry of the device is tilted to +30 degrees (forward tilt). A hazard to the operator/user presents itself if the operator puts his or her fingers or hand inside the gap and the gantry tilt is returned in position while the fingers o |
Integra Neurosciences PR; Inc. | Feb-16-2012 | INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only – "***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14 g; 3.5"***Plainsboro; NJ***"Needle for lumbar peritoneal shunt | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
Integra Neurosciences PR; Inc. | Feb-16-2012 | INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only – "***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro; NJ***"Collars for lumbar peritoneal shunt | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
Integra Neurosciences PR; Inc. | Feb-16-2012 | INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only – "***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14g; 6"***Plainsboro; NJ***"Needle for lumbar peritoneal shunt | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
Integra Neurosciences PR; Inc. | Feb-16-2012 | INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only – "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD; Total Length: 8"***Plainsboro; NJ***"Stainless steel stylet for ventricular catheter | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
Integra Neurosciences PR; Inc. | Feb-16-2012 | INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single Use Only – "***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single Use Only***Small OD .047"; Large OD .058"***Plainsboro; NJ***"Step down connector to be secure with ligature | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
Siemens Healthcare Diagnostics; Inc. | Feb-16-2012 | Dade(R) Actin(R) FSL Activated PTT Reagent – Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage:Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent with increased sensitivity to lupus-like inhibitors for use in the determination of the activated partial thromboplastin time (APTT) and related coagulation procedures. | The listed lots of Dade(R) Actin(R) FSL Reagent show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control; low and high. |
bioMerieux; Inc. | Feb-16-2012 | SLIDEX Staph kit – SLIDEX Staph kit (250 Tests).The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media. | Reports of false negative results in organism identification. |
Diagnostica Stago; Inc. | Feb-16-2012 | STA System Control N+P – STA – System Control N + PProduct Usage:The STA¿ -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STA¿brand name suitable to these reagents: -the Reagent 1 (STA¿-System Control N)is for the following tests: prothrombin time (PT); activated partial thromboplastin time (APTT); fibrinogen (Clauss method); thrombin time (TT); Reptilase¿¿ time; factors II; V; VII; VIII; IX; X; XI and XII; antithrombin (AT); protein C; protein S; plasminogen and antiplasmin. -the Reagent 2 (STA¿¿ -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase¿¿ time. Do not use the STA¿¿ -System Control N+P kit on STA Satellite¿ for the control of the APTT performed with the STA¿¿-rTT kit. | Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P. |
Leica Microsystems; Inc. | Feb-16-2012 | Leica M822 Surgical Microscope – Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6; pack F; affecting the control unit component; Article #10448446; in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit; article #10448587; Leica Microsystems (Schweiz) AG; Max Schmidheiny-Strasse 201; CH-9425; Heerbrugg; SwitzerlandThe intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. | Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use. |
Toshiba American Medical Systems Inc | Feb-15-2012 | TSX-301A: AQUILION ONE; System; X-Ray; Tomography; Computed – TSX-301A: AQUILION ONE; System; X-Ray; Tomography; ComputedLast four of Serial Number:2005; 2008; 2010; 2023; 2026; 2034; 2036; 2038; 2048; 2049; 2051; 2052; 2053; 2061; 2063; 2067; 2070; 2071; 2072; 2077; 2080; 2092; 2115; 2116; 2123; 2131; 2133; 2139; 2143; 2148; 2151; 2158; 2161; 2162; 2165; 2167; 2168; 2169; 2170; 2174; 2208; 2211; 2212; 2219; 2220; 2222; 2241; 2253; 2257; 2265; 2275; 2283; 2284; 2291; 2294; 2308; 2311; 2316; 2324; 2328; 2332; 2333; 2006; 2007; 2008; 2011; 2014; 2015; 2016; 2017; 2018; 2019; 2020; 2021; 2022; 2025; 2027; 2030; 2031; 2032; 2033; 2035; 2002; 2004.Aquilion One is a multislice CT system that supports whole body scanning. The system supports simultaneous data aquisition of 320 slices using the Selectable Slice-thickness Multi-row Detector (SSMD). In addition; the high speed rotation mechanism and the reconstruction unit of the system allow quick image acquisition to further improve throughput in CT examinations. Aquilion ONE; Toshiba’s top of the line X-ray CT system; is provided with a 7.5 MHU large capacity X-ray tube unit and detector and permits scanning at the high speed per rotation. | The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One. |
Toshiba American Medical Systems Inc | Feb-15-2012 | TSX-301B: AQUILION ONE; System; X-Ray; Tomography; Computed – TSX-301B: AQUILION ONE; System; X-Ray; Tomography; ComputedLast four of Serial Number:2005; 2008; 2010; 2023; 2026; 2034; 2036; 2038; 2048; 2049; 2051; 2052; 2053; 2061; 2063; 2067; 2070; 2071; 2072; 2077; 2080; 2092; 2115; 2116; 2123; 2131; 2133; 2139; 2143; 2148; 2151; 2158; 2161; 2162; 2165; 2167; 2168; 2169; 2170; 2174; 2208; 2211; 2212; 2219; 2220; 2222; 2241; 2253; 2257; 2265; 2275; 2283; 2284; 2291; 2294; 2308; 2311; 2316; 2324; 2328; 2332; 2333; 2006; 2007; 2008; 2011; 2014; 2015; 2016; 2017; 2018; 2019; 2020; 2021; 2022; 2025; 2027; 2030; 2031; 2032; 2033; 2035; 2002; 2004.Aquilion One is a multislice CT system that supports whole body scanning. The system supports simultaneous data aquisition of 320 slices using the Selectable Slice-thickness Multi-row Detector (SSMD). In addition; the high speed rotation mechanism and the reconstruction unit of the system allow quick image acquisition to further improve throughput in CT examinations. Aquilion ONE; Toshiba’s top of the line X-ray CT system; is provided with a 7.5 MHU large capacity X-ray tube unit and detector and permits scanning at the high speed per rotation. | The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One. |
European Custom Manufacturing B.V. | Feb-15-2012 | Temporary Pacing Wire – Temporary Pacing Wire; BIPOLAR; Models BM; V; VE and VF; Rx Only; STERILE/EO; Single use only — Mce (MEDICAL CONCEPTS EUROPE) — Manufacturer ECM B.V. Oost-Om 54; P.O. Box 53; NL 5420 AB GEMERT — Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. — Device Classification Name: Electrode; pacemaker; temporary. —The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached; after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less. | The crimping operation during product production was not performed properly. As such; the pacing wire may separate from the connection pin; which causes non-functionality. |
Orthofix; Inc. | Feb-15-2012 | Rotating Cutter – Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter); 89-0454 (10mm Rotating Cutter); and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium. | The 8mm and 10mm Rotating Cutters may fracture during use; specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use; it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment. |
Cordis Corporation | Feb-15-2012 | S.M.A.R.T. CONTROL Transhepatic Biliary Stent – S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree. Model numbers are CxxyyyMB; CxxyyySB; CxxyyyML; and CxxyyySL; where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T¿ CONTROL in the logo/description. All unexpired lot numbers 15112447 through 15525516. | Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches. |
Cordis Corporation | Feb-15-2012 | S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC – S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic atherosclerotic disease of the iliac arteries. catalog numbers are CxxyyyMB; CxxyyySB; CxxyyyML; and CxxyyySL; where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T.¿ CONTROL¿ in the logo/description. All unexpired lots from 15112447 through 15525516. | Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Nitinol Iliac Stent System due to a potential sterility breach in the pouches. |
Viterion TeleHealthcare Llc | Feb-15-2012 | Viterion 100 TeleHealth Monitor – Viterion 100-BGM TeleHealth Monitor; Model No. 09377512; Product Code/Part No. 81842478; Bayer HealthCare LLC 555 White Plains Road; Tarrytown; NY 10591-5097 USA — Manufactured in Japan for Bayer HealthCare LLC — Common Name: Viterion100 TeleHealth Monitor — Classification Name: Monitor; Physiological; Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300]Product Usage:The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect; accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner; and provides communication between the patient and the practitioner. The physiological monitoring instrument; selected by the healthcare practitioner; operates in conjunction with the Patient Terminal located in the patients home; a hospital room; nursing home; or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system; and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather; the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor. | Software defect; Specifically; blood glucose (BG) results from the Roche Aviva meter that are tagged by the user with either the meter hypoglycemic or general "asterisk" flags (*) will not be automatically transmitted through the Viterion 100-BGM monitor containing software version 3.2.0 or displayed to the health care provider through the data server. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 46mm GROUP B; REF DSBFGB46; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 76mm GROUP K; REF DSBFGK76; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 48mm GROUP B; REF DSBFGB48; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 50mm GROUP C; REF DSBFGC50; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 52mm GROUP D; REF DSBFGD52; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 54mm GROUP E; REF DSBFGE54; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 56mm GROUP F; REF DSBFGF56; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 58mm GROUP G; REF DSBFGG58; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 60mm GROUP G; REF DSBFGG60; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 62mm GROUP G; REF DSBFGG62; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 64mm GROUP H; REF DSBFGH64; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 66mm GROUP H; REF DSBFGH66; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 68mm GROUP H; REF DSBFGH68; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 70mm GROUP J; REF DSBFGJ70; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 72mm GROUP J; REF DSBFGJ72; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
Wright Medical Technology Inc | Feb-14-2012 | DYNASTY(R) BIOFOAM(R) SHELL – DYNASTY(R) BIOFOAM(R) SHELL; SIZE: 74mm GROUP J; REF DSBFGJ74; Rx ONLY; STERILE R; Wright Medical Technology; Inc.; hip prosthesis acetabular component.The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. |
St Jude Medical Inc | Feb-14-2012 | 1500T9 Cardiac Ablation Generator – The 1500T9 Cardiac Ablation Generator; RO#lBl-89000 is part of the Therapy Cardiac Ablation System; along with the Cool Point irrigation Pump; the Therapy 1300 Series Steerable Ablation Catheters; the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output delivered from the generator between its tip electrode and a dispersive pad for the treatment of atrial flutter. | Two St Jude Medical 1500T9 RF Generator units were distributed to customers while still under FDA review as part of a PMA supplement to the approved PMA applications. |
Cardiopulmonary Instrumentation; Inc | Feb-14-2012 | CI Healthcare Stainless Steel Patient Transport Stretcher – CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN; 2010 MADE IN CHINA***cihealthcare.comThis stainless steel stretcher is used for transporting patients. | Cardiopulmonary Instrumentation; Inc. dba CI Healthcare; Miami; FL; is recalling their Stainless Steel Patient Transport Stretcher; model # CI-8092; Lot 002; because of a malfunction that occurs when weight is applied to the backrest. This malfunction causes the backrest support bar; when secured in the first hook; to fall to a flat position. |
Inverness Medical | Feb-14-2012 | West Nile Virus IgM Capture ELISA – West Nile Virus IgM Capture ELISAThe Panbio West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis/meningitis. Positive results must be confirmed by plaque reduction neutralization test (PRNT); or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood; neonate; prenatal screening; general population screening without symptoms of meningoencephalitis or automated instruments. The user is responsible for establishing these assay performance characteristics. | It has come to our attention that users of these product lots may experience an elevation in the rate of false positivity when compared with previous product lots. Internal quality assurance testing has shown that the products are performing within the release specifications; although there has been a slight shift in the cut-off which may lead to an increase in the number of positive results obta |
Covidien LP | Feb-13-2012 | Covidien – DUET TRS 60 3.5MM STRAIGHT SULUProduct Code: DUET6035Product Usage:The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
Covidien LP | Feb-13-2012 | Covidien – DUET TRS 60 4.8MM ARTICULATING SULU Product Code: DUET6048AProduct Usage:The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. When used with the ENDO GIA Universal and Ultra Staplers; the Duet TRS Reloads with Biosyn tissue reinforcement place two; triple-staggered rows titanium staples while simultaneously dividing the tissue and anchoring the preloaded Biosyn reinforcement material. The preloaded reinforcement material Is fully detached from the SULU upon complete firing of the length of the cartridge. The Duet TRS reinforcement material (Biosyn) Is a synthetic absorbable film prepared from synthetic polyester composed of glycolide; dioxanone; and trimethylene carbonate. | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
Covidien LP | Feb-13-2012 | Covidien – DUET TRS 60 4.8MM STRAIGHT SULUProduct Code: DUET6048Product Usage:The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
Covidien LP | Feb-13-2012 | Covidien – DUET TRS 60 3.5MM ARTICULATING SULU Product Code: DUET6035AProduct Usage:The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
Covidien LP | Feb-13-2012 | Covidien – DUET TRS 45 4.8MM ARTICULATING SULU Product Code: DUET4548AProduct Usage:The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
Covidien LP | Feb-13-2012 | Covidien – DUET TRS 45 3.5MM STRAIGHT SULU Product Code: DUET4535Product Usage:The ENDO GIA Universal Staplers with DUET TRS Loading Units have applications in abdominal; gynecologic and pediatric surgery for resection; transection; and creation of anastomosis. They may be used for transaction and resection of liver substance; hepatic vasculature and biliary structures and for transection and resection of pancreas. | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
Covidien LP | Feb-13-2012 | Covidien – DUET TRS 45 3.5MM ARTICULATING SULU Product Code: DUET4535AProduct Usage:The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
Covidien LP | Feb-13-2012 | Covidien – DUET TRS 45 4.8MM STRAIGHT SULUProduct Code: DUET4548Product Usage:The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal; gynecologic; pediatric and thoracic surgery for resection; transection and creation of anastomosis. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures. | Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death |
Veridex; LLC | Feb-13-2012 | CellTracks Analyzer II – CellTracks Analyzer II.A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device. | Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II. |
Bio-Detek; Inc. | Feb-13-2012 | Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) – Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE)Part number: 8900-0401Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients. | Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter. |
DeRoyal Processing Center | Feb-13-2012 | DeRoyal(R) TRAUMA CRANIOTOMY PACK – Custom surgical kits:DeRoyal(R) TRAUMA CRANIOTOMY PACK; REF 89-7639.01; STERILE EO; Manufactured by: DeRoyal Industries; Inc.; Powell; TN 37849DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK; REF 89-7639.01; STERILE EO; Manufactured by: DeRoyal Industries; Inc.; Powell; TN 37849DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK; REF 89-7639.02; STERILE EO; Manufactured by: DeRoyal Industries; Inc.; Powell; TN 37849surgical kits | The firm distributed surgical kits which contained DermaHook Neuro Elastic Retractors which were subsequently recalled by Teleflex. |
Cytophil; Inc | Feb-13-2012 | Periophil Biphasic Periophil Biphasic; Periobase Biphasic; and Periobone Biphasic – Model #03001-02: Periophil Biphasic; Synthetic Biphasic Dental Bone Graft Granules; 1.0 cc. Model # 03003-01 Periobase Biphasic: Periobase; Synthetic Biphasic Dental Bone Biphasic Granules; 0.5 cc. Model #03002-01: Periobone Biphasic; Synthetic HA/TCP Dental Bone Graft Biphasic Granules; 0.5 cc. Periophil Biphasic (synthetic grafting material) is intended for use as a bone grafting material to fill; augment; or reconstruct periodontal or oral/maxillofacial defects. Cytophil; Inc.; 2485 Corporate Circle; Suite 2; East Roy; WI 53120. | Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic; Periobase Biphasic; and Periobone Biphasic because devices were inadvertently shipped after receiving an inadequate dose of radiation and this product may not be sterile. |
Trumpf Medical Systems; Inc. | Feb-13-2012 | TruLight ALC+; Trulight 5520 or 5320 lighting system. – Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. | The ALC+ function may not be properly locked during use resulting in the possibility of the handle falling off into the surgical field causing injury to the patient. |
Becton Dickinson & Company | Feb-13-2012 | Becton Dickinson 30G1/2" Precision Glide" Needle – BD 30G1/2" Precision Glide" NeedleNeedles are used for aspiration and injection of medications | Becton Dickinson has identified clogged needles. |
Sybron Dental Specialties | Feb-13-2012 | Material; tooth shade; resin – Artiste Flowable Part Number N28A; Syringe Lot Number 165741The intended use of the device is as a light cured; low viscosity; hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions; porcelain repairs; small core build-ups; fill-in of surface enamel irregularities; etc. | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. |
Radiometer America Inc | Feb-13-2012 | Crea Calibration solution – S1827 Crea Calibration solution 1; 944-135; Lot DV-02 Radiometer Medical; Bronshoj DenmarkProduct Usage:The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8×7 series creatine analyzers to establish calibration points for measured parameters. | When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle; the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong; and results in a bias on the Crea results. |
Sybron Dental Specialties | Feb-13-2012 | Artiste Flowable Value Pack – Artiste Flowable Value Pack Part Number N28VA; Syringe Lot Number 165741The intended use of the device is as a light cured; low viscosity; hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions; porcelain repairs; small core build-ups; fill-in of surface enamel irregularities; etc. | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. |
Sybron Dental Specialties | Feb-13-2012 | Flow Tec – Flow Tec Part Number 3784-514; Syringe Lot Number 165741The intended use of the device is as a light cured; low viscosity; hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions; porcelain repairs; small core build-ups; fill-in of surface enamel irregularities; etc. | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. |
Sybron Dental Specialties | Feb-13-2012 | Flow Tec – Flow Tec Part Number 3786-754; Syringe Lot Number 165741The intended use of the device is as a light cured; low viscosity; hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions; porcelain repairs; small core build-ups; fill-in of surface enamel irregularities; etc. | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. |
Sybron Dental Specialties | Feb-11-2012 | Artiste Flowable and Flow Tec (private label of Artiste Flowable) – Flow Tec Nano-Hybrid Flowable Affected ProductSyringe Part No. Value Pack Part. No. ShadeBEN3784-514 BEN3786-754 A1BEN3784-532 BEN3786-763 A2BEN3784-541 BEN3784-738 A3BEN3784-550 BEN3784-747 A3.5BEN3784-569 BEN3784-756 A4BEN3784-578 BEN3784-765 B1BEN3784-596 BEN3784-774 B2BEN3784-603 BEN3784-783 C1BEN3784-612 BEN3784-792 C2BEN3784-621 BEN3784-809 C3BEN3784-649 BEN3784-818 D2BEN3784-722 BEN3784-818 Universal OpaqueBEN3784-685 BEN3784-827 A0BEN3784-701 BEN3784-836 Incisal.The intended use of this device is as a light cured; low viscosity; hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions; porcelain repairs; small core build-ups; fill-in of surface enamel irregularities; etc. | The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude. |
Sybron Dental Specialties | Feb-11-2012 | Artiste Flowable and Flow Tec (private label of Artiste Flowable) – Artiste Nano-Hybrid Affected Product.Syringe Part No. Value Pack Part. No ShadeN28A N28VA A1N28B N28VB A2N28C N28VC A3N28D N28VD A3.5N28E N28VE A4N28F N28VF B1N28G N28VG B2N28J N28VJ C1N28K N28VK C2N28L N28VL C3N28N N28VP D2N28R N28VR Universal OpaqueN28XA N28VXA A0N28XC N28VXC Incisal.The intended use of this device is as a light cured; low viscosity; hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions; porcelain repairs; small core build-ups; fill-in of surface enamel irregularities; etc. | The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude. |
Philips Medical Systems (Cleveland) Inc | Feb-10-2012 | AXIS SPECT Systems & IRIX SPECT Systems – Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems; Model #: AXIS- 882130; IRIX- 882140. Philips Healthcare.Used to do nuclear medicine diagnostic imaging of various body organs. | Philips was informed that the detector buckets may experience weakness over time. As a result; this could cause the detector bucket to separate from the mounting plate of the gantry and eventually result in the detector falling. |
Linvatec Corp. dba ConMed Linvatec | Feb-10-2012 | ConMed Linvatec 2.9MM Full Radius Resector – ***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LARGO; FL 33773-4908 USA***ConMed Linvatec Biomaterials; Ltd.Hermiankatu 6-8L 33720 Tampere; FINLAND.***Lot number # 95987.Soft Tissue resection and removal. | ConMed Linvatec; Largo; FL recalled catalog number; C9944A; lot # 95987; 2.9MM Full Radius Resector Blade in November 2009 because there was a possibility that the device was assembled with an incorrect outer tube. |
Integra LifeSciences Corp | Feb-08-2012 | Integra – Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty; combined with bone marrow aspirate; is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect); Integra OS Putty is resorbed and replaced with bone during the healing process. | Integra OS Osteoconductive Putty is labeled with incorrect storage conditions. |
GE Healthcare; LLC | Feb-08-2012 | GE MR Systems – GE Healthcare Signa; Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR System; 1.5T Infinity TwinSpeed; Signa Lx; Signa Infinity MR System with EXCITE Technology; Excite II; Signa Excite 1.5T Expert; Signat 3T Infinity with Excite; Signa 3.0T with EXCITE; Signa Excite 1.5T and Signa Excite 3T; Signa Excite HD; Signa HD 1.5T and Signa HD 3.0T; Signa HDx; Signa HDxt; Signa Vibrant; Signa HDi; Signa Horizon Cx aka MR/I; Discovery MR450; Discovery MR750; Optima MR450w; Signa Cvi; and Signa Nvi.The Optima MR45Ow is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. it is indicated for use as a diagnostic imaging device to produce axial; sagittal; coronal; and oblique anatomical images; spectroscopic data; parametric maps; or dynamic images of the structures or functions of the entire body. The indication for use includes; but is not limited to; head; neck; TMJ; spine; breast; heart; abdomen; pelvis; joints; prostate; blood vessels; and musculoskeletal regions of the body. Depending on the region of interest being imaged; contrast agents may be used. The images produced by the Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra; when interpreted by a trained physician yield information that may assist in diagnosis. | GE Healthcare has become aware of missing labels on the alignment lasers. |
Philips Healthcare Inc. | Feb-08-2012 | Philips MultiDiagnost Eleva IITV – MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1Product Code 708036Product Usage:The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F; Fluoroscopy; Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system; Skeletal system; Urinary system; Reproductive system; Respiratory system; Circulatory system; and Various: Arthrograms; Myelograms; Facet joint injections; Discography; Sialography. | Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low |
Ortho-Clinical Diagnostics | Feb-08-2012 | VITROS¿ Valproic Acid (VALP) Reagent – VITROS¿ Valproic Acid (VALP) Reagent; REF/Catalog No. 6801710 — Ortho- Clinical Diagnostics Rochester; NY USA — Ortho- Clinical Diagnostics High Wycombe; UK — An in vitro diagnostic. For in vitro diagnostic use only. Used to quantitatively measure valproic acid (VALP) concentration in human serum and plasma. | Results using VITROS? Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were also affected by this issue. |
Beckman Coulter Inc. | Feb-07-2012 | AU Clinical Chemistry Analyzers – AU Clinical Chemistry Analyzers: Model Number:AU400 Clinical Chemistry Analyzer;AU400(e) Clinical Chemistry Analyzer;AU480 Clinical Chemistry Analyzer.The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric; turbidimetric; latex agglutination; and homogeneous enzyme immunoassay. | The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow. |
Beckman Coulter Inc. | Feb-07-2012 | AU Clinical Chemistry Analyzers – AU Clinical Chemistry Analyzers: Model Number: AU600 Clinical Chemistry Analyzer;AU640 Clinical Chemistry Analyzer;AU640(e) Clinical Chemistry Analyzer;AU680 Clinical Chemistry Analyzer.The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric; turbidimetric; latex agglutination; and homogeneous enzyme immunoassay. | The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow. |
Beckman Coulter Inc. | Feb-07-2012 | AU Clinical Chemistry Analyzers – AU Clinical Chemistry Analyzers: Model Number:AU2700 Clinical Chemistry Analyzer .The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric; turbidimetric; latex agglutination; and homogeneous enzyme immunoassay. | The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow. |
Siemens Healthcare Diagnostics | Feb-07-2012 | Siemens CLINITEST hCG¿ – Siemens CLINITEST hCG -Pregnancy Test (qualitative); Radio immunoassay;Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105).For in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. | A potential for false positive or increase in borderline results with patients and commercially available negative control material. |
Beckman Coulter Inc. | Feb-07-2012 | AU Clinical Chemistry Analyzers – AU Clinical Chemistry Analyzers: Model Number:AU5400 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric; turbidimetric; latex agglutination; and homogeneous enzyme immunoassay. | The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow. |
Terumo Cardiovascular Systems Corporation | Feb-07-2012 | Sarns Sternal Saw I System – Terumo; Sarns Sternal Saw I System; Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery. | Terumo Cardiovascular Systems has received one report of minute metal shavings leaking from the Sarns Sternal Saw I System at the point where the saw blade is inserted into the saw handpiece. |
Biosense Webster; Inc. | Feb-07-2012 | EZ Steer ThermoCool Nav – EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use.The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation; the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: – Type I atrial flutter in patients age 18 or older. – Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. – Drug refractory recurrent symptomatic paroxysmal atrial fibrillation; when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. | Biosense Webster; Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter:1. If phrenic nerve location is a concern; precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode; such as pacing maneuvers.2. To minimize risk of atrio-esophageal fist |
Biosense Webster; Inc. | Feb-07-2012 | EZ Steer ThermoCool Nav – EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use.The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation; the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: – Type I atrial flutter in patients age 18 or older. – Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. – Drug refractory recurrent symptomatic paroxysmal atrial fibrillation; when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. | Biosense Webster; Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter:1. If phrenic nerve location is a concern; precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode; such as pacing maneuvers.2. To minimize risk of atrio-esophageal fist |
Biosense Webster; Inc. | Feb-07-2012 | EZ Steer ThermoCool Nav – EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use.The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation; the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: – Type I atrial flutter in patients age 18 or older. – Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. – Drug refractory recurrent symptomatic paroxysmal atrial fibrillation; when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. | Biosense Webster; Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter:1. If phrenic nerve location is a concern; precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode; such as pacing maneuvers.2. To minimize risk of atrio-esophageal fist |
Biosense Webster; Inc. | Feb-07-2012 | EZ Steer ThermoCool Nav – EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use.The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation; the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: – Type I atrial flutter in patients age 18 or older. – Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. – Drug refractory recurrent symptomatic paroxysmal atrial fibrillation; when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. | Biosense Webster; Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter:1. If phrenic nerve location is a concern; precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode; such as pacing maneuvers.2. To minimize risk of atrio-esophageal fist |
Cincinnati Sub-Zero Products Inc | Feb-07-2012 | Hyper-Hypothermia System – Hemotherm 48¿C Dual Reservoir Heater/Cooler System; Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemotherm Dual Reservoir Heater/Cooler I provides a flow of temperature-controlled water to a heat exchanger. The device; in conjunction with a heat exchanger; is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Hemotherm does not contact the patient of the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C; the user must follow explicit instructions in to the owner’s manual in order to activate the higher setting. Without following the explicit instructions; the device can only operate within the normal maximum temperature range of: 42 degrees C. The Hemotherm can be used with adult and pediatric patients for extracorporeal circulation of the patient’s limb; entire body; or a chemo medication lavage of the abdominal area. The Hemotherm 48¿C device system is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature; as required; through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48¿C . | The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS and Cancer patients; were not appropriately cleared by the FDA prior to distribution. |
Cincinnati Sub-Zero Products Inc | Feb-07-2012 | Hyper-Hypothermia System – Blanketrol II 48¿C Hyper-Hypothermia System; Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48¿C System provides a flow of temperature-controlled water to a heat exchanger. The device; in conjunction with a heat exchanger; is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Blanketrol II 48 degree C does not contact the patient or the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C; the user must follow explicit instructions in to the owner’s manual in order to activate the higher setting. Without following the explicit instructions; the device can only operate within the normal maximum temperature range of: 42 degrees C. The Blanketrol II 48 Degree C System can be used with adult and pediatric patients for extracorporeal circulation of the patient’s limb; entire body; or a chemo medication lavage of the abdominal area. The 48¿C Blanketrol device is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature; as required; through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48 degrees C. | The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS or Cancer patients; were not appropriately cleared by the FDA prior to distribution. |
Biosense Webster; Inc. | Feb-07-2012 | EZ Steer ThermoCool Nav – EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use.The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation; the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: – Type I atrial flutter in patients age 18 or older. – Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. – Drug refractory recurrent symptomatic paroxysmal atrial fibrillation; when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. | Biosense Webster; Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter:1. If phrenic nerve location is a concern; precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode; such as pacing maneuvers.2. To minimize risk of atrio-esophageal fist |
Ortho-Clinical Diagnostics | Feb-07-2012 | VITROS¿ Chemistry Products Calibrator Kit 24 – VITROS¿ Chemistry Products Calibrator Kit 24; Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate the VITROS 5;1 FS Chemistry System; the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of albumin in urine. Ortho-Clinical Diagnostics Inc. | Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS? Chemistry Products Calibrator Kit 24 and VITROS? Chemistry Products mALB Reagent. |
Volcano Corporation | Feb-07-2012 | pcFM Software Kit – Volcano pcFM Software Kit ;Manufactured by: Volcano Corporation; 2870 Kilgore Road; Rancho Cardova; CA 95624.The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data. | Internal review of validation of pcMF Software kit found that instructions directs user to remove the rear panel; causing the potential for electric shock. |
Maquet Cardiovascular; LLC | Feb-06-2012 | XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. – XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners.Product Usage:The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart. | There may be a small perforation in the sterile pouch of select lots of the ACROBAT V; ACROBAT SUV; and ACROBAT Mechanical Stabilizers and the XPOSE 3 and XPOSE 4 Positioners. |
Maquet Cardiovascular; LLC | Feb-06-2012 | XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. – ACROBAT Stabilizers-ACROBAT V Vacuum Off-Pump System (OM-91 OOS); ACROBAT SUV Vacuum Off-Pump System (OM-9000S); ACROBAT Mechanical Off-Pump System (OM-6000S)Product Usage:The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart. | There may be a small perforation in the sterile pouch of select lots of the ACROBAT V; ACROBAT SUV; and ACROBAT Mechanical Stabilizers and the XPOSE 3 and XPOSE 4 Positioners. |
Stryker Medical Division of Stryker Corporation | Feb-06-2012 | Stryker EMS Stair -PRO – Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO); OE 2065939; 1739631; 2066066; 6066803 and 20666941 with optional ; Stryker Medical; Portage; MI 49002. Intended to provide the patient greater comfort and a sense of security. | The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. There is a moderate risk of injury to the patient should the handles become detached during use. |
Given Imaging Ltd. | Feb-06-2012 | Bravo pH Monitoring capsule – Bravo pH Monitoring capsule; UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313).Product Usage:The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. | Failure of the Bravo capsule to attach to the esophagus or alternatively; failure of the capsule to detach from the placement device. |
Alere San Diego | Feb-06-2012 | Alere Cholestech LDX System – Alere Cholestech LDX Analyzer; Model Number: 10-004; 14-874; 14-875; in vitro diagnostic. | Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability. |
Ossur H / F | Feb-06-2012 | Total Knee – Total Knee Junior Model Number 1100Product Usage:The Total Knee¿ Junior is an external polycentric prosthetic knee with a geometric locking system. | Some units of the Total Knee Junior produced between November 25th; 2008 and through April; 2009 contain balancing units that may fail under extreme use over a long period. The fault is noncritical and no incidents or injuries resulting from this situation have been reported to Ossur at this stage. Over long term use (estimated to be in the four to six year range) the prosthetic device may fail a |
DeRoyal Industries Inc | Feb-06-2012 | DeRoyal Surgical Kits and trays – Sterile surgical kits: DeRoyal SELECTIVE ARTERIOGRAM PACK; REF 89-7284.02 Lot Number: 26166359; DeRoyal UNIVERSAL PACK; REF 89-7237.01 Lot Number: 26013627; DeRoyal NEURO BASIC PACK; REF 89-7229.01 Lot number: 26013635; DeRoyal C-SECTION TRAY; REF 89-5256.06 Lot Number: 26185242; DeRoyal C V MINOR TRAY; REF 89-5277.02 Lot Number: 25793211; DeRoyal COMBINED EXTREMITY PACK; REF 89-6773.02 Lot Numbers: 25744022; 26010670; 26194641; DeRoyal DISKECTOMY TRAY; REF 89-6196.03 Lot Number: 26097373; DeRoyal MAJOR DRAPE PACK; REF 89-7255.01 Lot Number: 26011736; DeRoyal EXTREMITY PACK PGYBK; REF 89-5275.05 Lot Number: 26063270; DeRoyal SCOPE SHOULDER TRAY; REF 89-5653.03 Lot Number: 26227422; DeRoyal KNEE SCOPE PACK; REF 89-5654.03 Lot Number: 26020510; DeRoyal BILATERAL DRAPE; REF 89-5379.02 Lot Number: 26042735; 26282421; DeRoyal LAPAROSCOPIC CHOLE PACK; REF 89-5259.05 Lot Number: 25817201; DeRoyal MAJOR HIP PACK; REF 89-4718.04 Lot Number: 25840313; DeRoyal SPINE PACK; REF 89-4150.06 Lot Number: 25933077; DeRoyal ARTHROSCOPY TRAY; REF 89-5317.02 Lot Number: 26078463; DeRoyal LARGE VASCULAR TRAY; Lot Number: 26078447; DeRoyal SMALL VASCULAR TRAY; REF 89-3694.13 Lot Number: 261449399; DeRoyal ASC VASCULAR PACK PGYBK; REF 89-6284.05 Lot Number: 25698986; DeRoyal ASC BREAST PACK; REF 89-6285.06; Lot Number: 26078578; DeRoyal ASC FOOT/ANKLE PACK; REF 89-6014.07 Lot Numbers: 26096856; 26147916; DeRoyal ACUTE BURN EXCISION TRAY; REF 89-3330.05 Lot Number: 26078367; DeRoyal RECONSTRUCTION TRAY; REF 89-3331.04 Lot Numbers: 25817383; 26019720; DeRoyal FOOT PACK; REF 89-6467.05 Lot Number: 25880438; DeRoyal TRAUMA PACK; REF 89-6776.04 Lot Number: 26010688; DeRoyal KNEE ARTHROSCOPY PACK; REF 89-5257.08 Lot Numbers: 26125434; 26149102; DeRoyal CHILDRENs ORTHOPEDIC TRAY; REF 89-3479.08 Lot Numbers: 25873676; 25905092 DeRoyal KNEE SCOPE; REF 89-2910.09 Lot Number: 25695611; DeRoyal SPINE PACK PGYBK; REF 89-6720.01 Lot Number: 26022048; DeRoyal OPEN SHOULDER PROCEDURE PACK; REF 89-6629.01 Lot Number: 25839187; DeRoyal ORTHO TOTAL BASIC TRAY; REF 89-2650.15 Lot Numbers: 25893423; 26010207; 26077111; DeRoyal ORTHO TOTAL HIP/KNEE TRAY; REF 89-2644.17 A & B Lot Number: 25894012; DeRoyal MINOR/PLASTIC PACK; REF 89-6994.02 Lot Number: 25853544; DeRoyal OPEN HEART PACK; REF 89-6996.02 Lot Number: 25853608; DeRoyal GEN SURG UNIV PACK; REF 89-6991.02 Lot Number: 25696032; DeRoyal PERI VASCULAR PACK; REF 89-6998.03 Lot Number: 25853587; DeRoyal VASCULAR PACK; REF 50-4157.29 Lot Number: 25732507; DeRoyal OPEN HEART B; REF 50-13010.19 Lot Number: 26009978; DeRoyal GENERAL ORTHO PACK; REF 89-6883.02 Lot Number: 25695911; DeRoyal HIP COUNTABLES TRAY; REF 89-5382.03 Lot Number: 26020464; DeRoyal BASIC ORTHO TRAY; REF 89-3389.11 Lot Number: 26010291; DeRoyal TOTAL KNEE PACK; REF 89-7114.02 Lot Number: 26012780; DeRoyal ACF TRAY; REF 89-7660.01 Lot Number: 26022656; DeRoyal HAND PACK; REF 89-7549.02 Lot Numbers: 26042330; 26147713; DeRoyal ORTHO PACK; REF 89-7546.02 Lot Numbers: 26025242; 26025717; DeRoyal THORACOTOMY PACK; REF 89-7536.02 Lot Number: 26022161; DeRoyal LAPAROSCOPIC GYN PACK; REF 89-7500.02 Lot Number: 26096063; DeRoyal ELG/AAA PACK; REF 89-7495.02 Lot Number: 26256371; DeRoyal PEDI OPEN HEART PACK; REF 89-7486.02 Lot Number: 26100624; DeRoyal TOTAL KNEE PACK; REF 89-7484.01 Lot Number: 25875196; DeRoyal TOTAL KNEE PACK; REF 89-7466.01 Lot Number: 26013301; DeRoyal CUSTOM TOTAL HIP PACK; REF 89-7465.03 Lot Number: 26096039; 26166244; DeRoyal PERIPHERAL VASCULAR PACK; REF 89-7451.02 Lot Number: 26166252; DeRoyal NEURO PACK; REF 89-7396.01 Lot Number: 26061573; DeRoyal LABOR & DELIVER PACK; REF 89-7448.03 Lot Number: 26166236; DeRoyal SHOULDER ARTHROSCOPY PACK; REF 89-7446.02 Lot Number: 26096549; DeRoyal GENERAL MINOR PACK; REF 89-7365.01 Lot Numbers: 25838838; 26095765; DeRoyal CUSTOM GENERAL MAJOR PACK; REF 89-7357.01 Lot Nu | Custom surgical kits contain recalled Kimberly Clark surgical drapes which were found to contain metal shavings in the folds of the drapes. |
Philips Medical Systems (Cleveland) Inc | Feb-03-2012 | Brilliance Big Bore – Brilliance Big Bore Model #728243 and #728244; Philips Medical Systems.Computed Tomography X-Ray System intended to produce of x-ray transmission data taken at different angles and planes. | The Block and Multi Leaf Collimator (MLC) shape is not propagated to the beam that is modified by the Oppose operation. The contours can appear with the incorrect color in the Beam’s Eye View Viewer; resulting in organs being incorrectly placed or incorrectly shaped. |
Varian Medical Systems; Inc. Oncology Systems | Feb-03-2012 | Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL – Varian brand Varian Clinac Accelerators with Mark; Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL; Reference/FSCA CP-05591; Model Number: H53; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. | Failure to retract or park the Varian MLC leaves prior to use of the demountable BrainLAB m3 could result in the Varian MLC leaves interfering with the treatment field defined by the BrainLAB m3 without an interlock being asserted. |
Ascent Healthcare Solutions | Feb-03-2012 | DYONICS***Arthroscopic Blade – ***CAT 7205316***DYONICS***Arthroscopic Blade***4.5mm TURBOWHISKER; 13cm long***Fits Power/EP-1 Motor Drives***Navy Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 197855***Expiration Date: 12/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | DYONICS***Arthroscopic Burr – ***CAT 7205326***DYONICS***Arthroscopic Burr; Wide Mouth***4.0mm ACROMIONIZER; 13cm long***Fits Power/EP-1 Motor Drives***Mauve***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 195769***Expiration Date: 11/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | DYONICS***Arthroscopic Burr – ***CAT 7205330***DYONICS***Arthroscopic Burr; Wide Mouth***4.0mm STONECUTTER; 13cm long***Fits Power/EP-1 Motor Drives***Maroon***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 197857***Expiration Date: 12/2011.***CAT 7205331***DYONICS***Arthroscopic Burr; Wide Mouth***5.5mm STONECUTTER; 13cm long***Fits Power/EP-1 Motor Drives***Olive***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 194244***Expiration Date: 11/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | DYONICS***Arthroscopic Blade – ***CAT 7205345***DYONICS***Arthroscopic Blade***4.5mm INCISOR PLUS; 13cm long***Fits Power/EP-1 Motor Drives***Violet***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 197940***Expiration Date: 12/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | STRYKER***Arthroscopic Blade – ***CAT 275-542-000***STRYKER***Arthroscopic Blade***4.0mm RESECTOR***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 195024***Expiration Date: 11/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | STRYKER***Arthroscopic Burr – ***CAT 275-941-000***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR Hollow 6 Flute***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 194652***Expiration Date: 11/2011.***CAT 275-951-000***STRYKER***Arthroscopic Burr***5.5mm BARREL BUR Hollow 6 Flute***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 200401***Expiration Date: 11/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | STRYKER***Arthroscopic Blade – ***CAT 375-545-000***STRYKER***Arthroscopic Blade***4.0mm TOMCAT CUTTER***Hub Style – Formula***Red/White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 203562***Expiration Date: 01/2012.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | STRYKER***Arthroscopic Blade – ***CAT 375-544-000***STRYKER***Arthroscopic Blade***4.0mm AGGRESSIVE PLUS***Hub Style – Formula***Red/Lt Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 200860***Expiration Date: 01/2012.***CAT 375-554-000***STRYKER***Arthroscopic Blade***5.0mm AGGRESSIVE PLUS***Hub Style – Formula***Red/Lt Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 200860***Expiration Date: 01/2012.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | STRYKER***Arthroscopic Blade – ***CAT 275-534-000***STRYKER***Arthroscopic Blade***3.5mm AGGRESSIVE PLUS***Yellow/Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 196504***Expiration Date: 11/2011.***CAT 275-544-000***STRYKER***Arthroscopic Blade***4.0mm AGGRESSIVE PLUS***Red/Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 196486***Expiration Date: 11/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | STRYKER***Arthroscopic Blade – ***CAT 375-532-000***STRYKER***Arthroscopic Blade***3.5mm RESECTOR***Hub Style – Formula***Yellow/Black***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 195749***Expiration Date: 11/2011.***CAT 375-542-000***STRYKER***Arthroscopic Blade***4.0mm RESECTOR***Hub Style – Formula***Red/Black***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 199469***Expiration Date: 12/2011.***CAT 375-562-000***STRYKER***Arthroscopic Blade***5.5mm RESECTOR***Hub Style – Formula***Tan/Black***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 192516***Expiration Date: 10/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | STRYKER***Arthroscopic Burr – ***CAT 375-941-000***STRYKER***Arthroscopic Bur***4.0mm BARREL BUR***Hollow 6 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 198025***Expiration Date: 11/2011.***CAT 375-951-000***STRYKER***Arthroscopic Bur***5.5mm BARREL BUR Hollow 6 Flute***TAN***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 199469***Expiration Date: 12/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | STRYKER***Arthroscopic Burr – ***CAT 375-941-012***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR***Hollow 12 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 195182***Expiration Date: 11/2011.***CAT 375-951-112***STRYKER***Arthroscopic Burr***5.0mm BARREL BUR***Hollow 12 Flute***BLUE***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 194245***Expiration Date: 11/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | LINVATEC***Arthroscopic Blade – ***CAT#: 9297A***LINVATEC***Arthroscopic Blade***4.8mm GREAT WHITE; 13cm long***Qty: 6***Large Hub***White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 193794***Expiration Date: 10/2011.***CAT #: 9299A***LINVATEC***Arthroscopic Blade***4.2mm GREAT WHITE; 13cm long***Qty: 6***Large Hub***White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 193534***Expiration Date: 10/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | DYONICS***Arthroscopic Blade – ***CAT 7205314***DYONICS***Arthroscopic Blade***5.5mm INCISOR; 13cm long***Fits Power/EP-1 Motor Drives***Mocha***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 197849***Expiration Date: 12/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | DYONICS***Arthroscopic Blade – ***CAT 7205305***DYONICS***Arthroscopic Blade***3.5mm FULL RADIUS; 13cm long***Fits Power/EP-1 Motor Drives***Beige***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 199468***Expiration Date: 12/2011.***CAT 7205306***DYONICS***Arthroscopic Blade***4.5mm FULL RADIUS; 13cm long***Fits Power/EP-1 Motor Drives***Yellow***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 185659***Expiration Date: 08/2011.***CAT 7205307***DYONICS***Arthroscopic Blade***5.5mm FULL RADIUS; 13cm long***Fits Power/EP-1 Motor Drives***Orange***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 197755***Expiration Date: 12/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Ascent Healthcare Solutions | Feb-03-2012 | DYONICS***Arthroscopic Blade – ***CAT 7205310***DYONICS***Arthroscopic Blade***4.5mm SYNOVATOR; 13cm long***Fits Power/EP-1 Motor Drives***Forest Green***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland; FL*** Lot number: 197854***Expiration Date: 12/2011.Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints; jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | On 01/26/2009; Ascent Healthcare Solutions; Lakeland; FL initiated a recall of various models of Dyonics; Stryker; and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
Philips Medical Systems (Cleveland) Inc | Feb-02-2012 | Philips Medical Systems GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System – GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System; Philips Medical Systems; Cleveland; OHThe device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body; head; heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode; dynamic; and gated acquisitions. Image processing and display workstations provide software applications to process; analyze; display; quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: -The evaluation; detection and diagnosis of lesions; disease and organ function such as but not limited to cancer; cardiovascular disease; and neurological disorders. -The detection; localization; and staging of tumors and diagnosing cancer patients. -Treatment planning and interventional radiology procedures. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. | Philips became aware of an issue relating to a UPS cabinet that contained a melted battery which caused damage to other batteries lower in the cabinet; leading to battery acid leaking on the floor. |
Siemens Medical Solutions USA; Inc | Feb-02-2012 | Siemens MAGNETOM Aera/Skyra – Siemens MAGNETOM Aera/Skyra; model numbers 10432914 and 10432915.Nuclear magnetic resonance imaging system. | During product monitoring firm has discovered that on a few systems the gradient cable connections did not meet their specifications after installation. Locally; the cable connections overheated; making servicing necessary. The potential existed for a cable connection to become overheated; leading to the emission of smoke and possible material damage. Firm preventively checked the gradient cabl |
Vital Signs Devices; a GE Healthcare Company | Feb-02-2012 | Vital Signs – Broselow/Hinkle Pediatric Emergency SystemVital Signs Inc.20 Campus RoadTotowa; NJ 07512 USAThe system supplies you with all the information and equipment needed for a young patients’ emergency resuscitation requirements; all contained in a color coded; easy-to-use kit | Povidone Iodine Pads included in the Vital Signs Broselow Pediatric Emergency Kit may be contaminated with Elizabethkinga meningoseptica. |
Kimberly-Clark Corporation | Feb-02-2012 | KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE – KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE; 22F.Gastro-Enteric Feeding Tube. | The product is misbranded; i.e. the Gastric (center) port may be mislabeled as the Jejunal port; and the Jejunal (side) port mislabeled as the Gastric port. |
Philips Healthcare Inc. | Feb-02-2012 | Philips MultiDiagnost Eleva FD (MD-FD) – Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1Product Code 708037Product Usage:The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F; Fluoroscopy; Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system; Skeletal system; Urinary system; Reproductive system; Respiratory system; Circulatory system; and Various: Arthrograms; Myelograms; Facet joint injections; Discography; Sialography. | The skin dose and skin dose rate values are calculated using an incorrect point of reference. Therefore; the AKR as displayed and stored in patient records is too low; although the dose as received by the patient is not affected. |
Toshiba American Medical Systems Inc | Feb-02-2012 | DRAD-3000E Radrex-i X-ray System – DRAD-3000E: Radrex-i X-Ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***" | It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable. |
Edwards Lifesciences; Llc | Feb-02-2012 | Vigilance II Monitor – Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51; 00.60; 00.61; 00.62; 00.63; 00.64; 00.67; 00.69;00.71; 00.73.Product Usage:The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters; including cardiac output; oximetry and right ventricular; ejection; fraction; and end diastolic volume. | Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51; 00.60; 00.61; 00.62; 00.63; 00.64; 00.67; 00.69; 00.71; 00.73 due to the potential of inaccurate Injectate Cardiac Output (ICO) measurements. |
Volcano Corporation | Feb-01-2012 | Volcano FloWire Doppler Guidewire – FloWire Doppler Guide wires.Volcano Corporation;Rancho Cardova; Ca.The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary and peripheral arteries to measure blood flow velocities during diagnostics angiography and/or interventional procedures. | Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap. |