The following document is a summary of some medical device safety information related to potentially hazardous cases. It only serves as a quick reference and in no way should be considered as exhaustive and up-to-date. Please refer to the source of information and your product supplier for details. (Updated on 12 August 2008).[Excel ]
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Medtronic Heparin-Coated products (8 May 2008) |
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Chattem Icy Hot Heat Therapy Air Activated Heat Adhesive Heating Patch - (i) Back; (ii) Arm, Neck, and Leg (25 February 2008) |
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GE AW 4.2, AW Volumeshare and AW Volumeshare 2 Image Visualization Workstations (26 November 2007) |
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Medtronic Sprint Fidelis Defibrillation Leads (15 October 2007) |
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Baxa Exacta-Mix 2400 OS v 1.07 (Model No. 8300-0073) Pharmacy Compounding System (4 October 2007) |
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MRL / Welch Allyn AED20 Automatic External Defibrillators (25 September 2007) |
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Abbott Blood Glucose Meters, Models: Precision Xtra, Optium, ReliOn Ultima, Rite Aid and Kroger (31 August 2007) |
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Gambro AK-95 and AK-95S Haemodialysis Units (20 August 2007) |
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Georg Kramer GES.M.B.H. & Co. KG - Atlantis Patient Lift Model 9500 (9 August 2007) |
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BHM Medical Nautica Patient Lift (9 August 2007) |
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Baxter COLLEAGUE, COLLEAGUE CX, and FLO-GARD Volumetric Infusion Pumps (27 July 2007) |
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Airox Legendair Ventilators (10 July 2007) |
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Chiltern Wispa Attachment Handles (10 July 2007) |
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Airox Legendair Ventilators Single/Double Bran (25 June 2007) |
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T. H. E. Medical Reacher Bar with Small Carabiner (28 May 2007) |
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Roche COBAS Integra Valproic Acid Assay (28 May 2007) |
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Thoratec Paracorporeal Ventricular Assist Device (14 May 2007) |
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ProCytech Medical Devices (7 May 2007) |
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Ortho- Clinical Diagnostics VITROS Troponin I Reagent Packs (Cat. No.: 194 9882) (4 May 2007) |
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Boston Scientific Vitality and Assure Implantable Cardioverter Defibrillator (ICD) Families and Contak Renewal Cardiac Resynchronisation Therapy Defibrillator (CRT-D) Families (15 March 2007) |
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Medtronic Model 3770GK GATEKEEPER Reflux Repair Systems (6 March 2007) |
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Waverleyglen Portable Reachers 24" and 36" (5 March 2007) |
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Various Models of HoMedics Heating Pads (9 February 2007) |
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Biomerieux Vironostika HIV-1 Microelisa Systems (7 February 2007) |
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Physio-Control Products (25 January 2007) |
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Select lots of CIBA Vision O2Optix (lotrafilcon B) Soft Contact Lenses (16 January 2007) |
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LifeScan OneTouch Ultra, LifeScan InDuo and LifeScan PocketScan Blood Glucose Meter (15 December 2006) |
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Smiths Medical 3404 BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor (13 December 2006) |
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Bard Ltd. Peripheral Saxx-Stent and Saxx Premounted Peripheral Stent Implantation System (8 December 2006) |
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Specific Lots of AMO Lens Plus OcuPure Saline, COMPLETE Multi-Purpose Solutions, and COMPLETE MoisturePLUS Multi-Purpose Solutions (Starter Kits) (22 November 2006) |
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BD Insulin Pen Needles, 31G 5mm, Catalog No. 320129 (15 November 2006) |
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Ciba Vision CSI Daily Wear, CSI Flexible Wear and CSI Toric soft (hydrophilic) contact lenses (15 November 2006) |
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Calley & Currier Laminated Wooden Crutches, various models and catalog numbers (13 November 2006) |
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Respironics REMstar Heated Humidifiers (9 November 2006) |
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Alcon Opti-Free Express Contact Lens Care Solution, Lot Number 63188F (31 October 2006) |
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LifeScan OneTouch SureStep Test Strips, Lot or Serial Number 2631383 (30 October 2006) |
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Sunrise Medical Canada 5in Wheels Kits and Guardian Walkers (30 October 2006) |
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BHM Medical Kwiktrak Fix Gate, Model or Catalog Number 700.11500 and 700.11505 (30 October 2006) |
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Eagle Parts and Products Models 624EZ and 624Mini Power Wheel Chairs (25 October 2006) |
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UPDATE: LifeScan, Inc, One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips (23 October 2006) |
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Medtronic SynchroMed EL Programmable Infusion Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18 (20 October 2006) |
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Sunrise Medical Jay J2, Wheelchair back (19 October 2006) |
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St. Jude Medical APS III Model 3500/3510 and Merlin PCS Model 3650 pacemakers programmers (13 October 2006) |
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LifeScan, Inc, One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips (13 October 2006, updated on 23 October 2006) |
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Alert Jenx Limited - seating support systems for children (12 October 2006) |
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Voluntary Limited Market Recall: AMO COMPLETE Amino Moist Multi-Purpose Solution (28 September 2006) |
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Sunrise Medical Jay J2, Wheelchair back (28 September 2006, superseded by the one on 19 October 2006) |
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Micro-Touch Ultra PF Powder Free Latex Examination Glove (20 September 2006) |
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Alert Regarding Roche Diagnostics Accu-chek Advantage Blood Glucose Meters (26 August 2006) |
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Urgent Medical Device Safety Information on BIOTRONIK Stratos LV-T Pacemakers (3 August 2006) |
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Voluntary Field Corrective Action: Medtronic Model 7428 Kinetra Implantable Neurostimulator (20 July 2006) |
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Voluntary Recall of Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps (14 July 2006) |
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