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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 2 July 2009).Excel PDF

  Respironics SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003) (19 May 2009)
 
  Medtronic Kappa 600/700/900 Series and Sigma 100/200/300 Series Pacemakers (19 May 2009)
 
  All Bioprosthetic Heart valves (18 May 2009)
 
  Cordis Cypher Select Sirolimus Eluting Coronary Stents (Hub Crack) (13 May 2009)
 
  Biosite Incorporated Triage Cardiac Panel (11 May 2009)
 
  Philips HeartStart MRx/MRxE M3535A/M3536A/M3536J Defirillator/Monitor (23 April 2009)
 
  Philips HeartStart XL M4735A Defibrillator/Monitor (23 April 2009)
 
  i-sens caresense BGA (17 April 2009)
 
  Abbott CELL-Dyn Ruby Hematology Analyzer (List no 08H67-01) (16 April 2009)
 
  Teleflex Medical (Arrow International Inc) 30, 40 and 50 cc Intra-Aortic Ballloon (16 April 2009)
 
  Johnson and Johnson (Animas) Ethicon Endo-Surgery Device - Ets-FLEX45 (16 April 2009)
 
  3M No Sting Barrier Film (Model 3346E) (3 April 2009)
 
  Roche Diagnostics Ambulatory insulin infusion pump Accu-Chek Spirit (6 April 2009)
 
  James Leckey Designs paediatric seating systems (31 Mar 2009)
 
  Astrazeneca NebuChamber (30 March 2009)
 
  Boston Scientific Flexima and Perculfex Drainage Catheter Family (Pigtail Style) (27 March 2009)
 
  Abbott Xience V Eluting Coronary Stent System, 2.5 x 28mm (25 March 2009)
 
  Medtronic Sprint Fidelis Lead (23 March 2009)
 
  Corona Medical Patient Beds (Side Rails) (20 March 2009)
 
  Philips GXR RF Systems with DI (EasyDiagnost Eleva) (19 March 2009)
 
  ConMed Fortis II (19 march 2009)
 
  BD Falcon 100 x 20 mm Tissue Culture - Treated Dish (BD Cat no. 353003) (17 March 2009)
 
  Sunrise Medical Quickie Groove battery powered wheelchairs (10 March 2009)
 
  Medtronic Physio-Control Lifepak 20 defibrillator / monitor - Keypad (10 March 2009)
 
  Welch Allyn AED 10 and former MRL Jumpstart Automated External Defibrillators (5 March 2009)
 
  DORC International MembraneBluec 0.5ml syringe (4 March 2009)
 
  James Leckey Advanced, Contoured Advanced, Squiggles Early Siting Searing Systems (10 February 2009)
 
  DORC international MembraneBlue © 0.5ml syringe (4 March 2009)
 
  Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator / Monitor (2 February 2008)
 
  Boston Scientific Gold Probe Singe-Use BiPolar Electrohemostasis Catheters (30 December 2008)

  Joerns Healthcare Oxford Disposable slings (23 December 2008)

  Sun Med Greenline/D Maclntosh No. 3 Laryngoscope Blades (22 December 2008)

  Integra NeuroScience Gravity Compensating Accessory (15 December 2008)

  AMO Healon D Ophthalmic Viscosurgical Device (Lot no. UD30654) (15 December 2008)

  Angio 3-0 Nylon Suture Product (17 November 2008)

  Joerns Healthcare Mermaid, Dipper and Ranger bath hoists (10 November 2008)

  Tyco Healthcare (Covidien) ReliOn Insulin Syringes (6 November 2008)

  Vibe Technologies, Vibrational Integrated Biophotonic Energizer (VIBE) Machine Multi-Frequency Field Generator (3 November 2008)

  Nebion, LLC HLX-8 Magnetic Resonance Device (6 October 2008)

  Medtronic INDURA 1P Intrathecal Catheter (Model 8709SC), Intrathecal Catheter (Model 8731SC), Sutureless Pump Connector Revision Kit (Model 8678) and Intrathecal Catheter Pump Segment Revision Kit (Model 8596SC) (2 October 2008)

  Various Hot/Cold Gel Pack (25 September 2008)

  Teleflex Weck Clips products : Hemolok clips, Horizon Clips and Hemoclip (12 September 2008)

  Johnson and Johnson ASP Automatic Endoscope Reprocessor (AER) (17 September 2008)

  Medtronic Heparin-Coated products (8 May 2008)

  Chattem Icy Hot Heat Therapy Air Activated Heat Adhesive Heating Patch - (i) Back; (ii) Arm, Neck, and Leg (25 February 2008)

  GE AW 4.2, AW Volumeshare and AW Volumeshare 2 Image Visualization Workstations (26 November 2007)

  Medtronic Sprint Fidelis Defibrillation Leads (15 October 2007)

  Baxa Exacta-Mix 2400 OS v 1.07 (Model No. 8300-0073) Pharmacy Compounding System (4 October 2007)

  MRL / Welch Allyn AED20 Automatic External Defibrillators (25 September 2007)

  Abbott Blood Glucose Meters, Models: Precision Xtra, Optium, ReliOn Ultima, Rite Aid and Kroger (31 August 2007)

  Gambro AK-95 and AK-95S Haemodialysis Units (20 August 2007)

  Georg Kramer GES.M.B.H. & Co. KG - Atlantis Patient Lift Model 9500 (9 August 2007)

  BHM Medical Nautica Patient Lift (9 August 2007)

  Baxter COLLEAGUE, COLLEAGUE CX, and FLO-GARD Volumetric Infusion Pumps (27 July 2007)

  Airox Legendair Ventilators (10 July 2007)

  Chiltern Wispa Attachment Handles (10 July 2007)

  Airox Legendair Ventilators Single/Double Bran (25 June 2007)

  T. H. E. Medical Reacher Bar with Small Carabiner (28 May 2007)

  Roche COBAS Integra Valproic Acid Assay (28 May 2007)

  Thoratec Paracorporeal Ventricular Assist Device (14 May 2007)

  ProCytech Medical Devices (7 May 2007)

  Ortho- Clinical Diagnostics VITROS Troponin I Reagent Packs (Cat. No.: 194 9882) (4 May 2007)

  Boston Scientific Vitality and Assure Implantable Cardioverter Defibrillator (ICD) Families and Contak Renewal Cardiac Resynchronisation Therapy Defibrillator (CRT-D) Families (15 March 2007)

  Medtronic Model 3770GK GATEKEEPER Reflux Repair Systems (6 March 2007)

  Waverleyglen Portable Reachers 24" and 36" (5 March 2007)

  Various Models of HoMedics Heating Pads (9 February 2007)

  Biomerieux Vironostika HIV-1 Microelisa Systems (7 February 2007)

  Physio-Control Products (25 January 2007)

  Select lots of CIBA Vision O2Optix (lotrafilcon B) Soft Contact Lenses (16 January 2007)

  LifeScan OneTouch Ultra, LifeScan InDuo and LifeScan PocketScan Blood Glucose Meter (15 December 2006)

  Smiths Medical 3404 BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor (13 December 2006)

  Bard Ltd. Peripheral Saxx-Stent and Saxx Premounted Peripheral Stent Implantation System (8 December 2006)

  Specific Lots of AMO Lens Plus OcuPure Saline, COMPLETE Multi-Purpose Solutions, and COMPLETE MoisturePLUS Multi-Purpose Solutions (Starter Kits) (22 November 2006)

  BD Insulin Pen Needles, 31G 5mm, Catalog No. 320129 (15 November 2006)

  Ciba Vision CSI Daily Wear, CSI Flexible Wear and CSI Toric soft (hydrophilic) contact lenses (15 November 2006)

  Calley & Currier Laminated Wooden Crutches, various models and catalog numbers (13 November 2006)

  Respironics REMstar Heated Humidifiers (9 November 2006)

  Alcon Opti-Free Express Contact Lens Care Solution, Lot Number 63188F (31 October 2006)

  LifeScan OneTouch SureStep Test Strips, Lot or Serial Number 2631383 (30 October 2006)

  Sunrise Medical Canada 5in Wheels Kits and Guardian Walkers (30 October 2006)

  BHM Medical Kwiktrak Fix Gate, Model or Catalog Number 700.11500 and 700.11505 (30 October 2006)

  Eagle Parts and Products Models 624EZ and 624Mini Power Wheel Chairs (25 October 2006)

  UPDATE: LifeScan, Inc, One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips (23 October 2006)

  Medtronic SynchroMed EL Programmable Infusion Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18 (20 October 2006)

  Sunrise Medical Jay J2, Wheelchair back (19 October 2006)

  St. Jude Medical APS III Model 3500/3510 and Merlin PCS Model 3650 pacemakers programmers (13 October 2006)

  LifeScan, Inc, One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips (13 October 2006, updated on 23 October 2006)

  Alert Jenx Limited - seating support systems for children (12 October 2006)

  Voluntary Limited Market Recall: AMO COMPLETE Amino Moist Multi-Purpose Solution (28 September 2006)

  Sunrise Medical Jay J2, Wheelchair back (28 September 2006, superseded by the one on 19 October 2006)

  Micro-Touch Ultra PF Powder Free Latex Examination Glove (20 September 2006)

  Alert Regarding Roche Diagnostics Accu-chek Advantage Blood Glucose Meters (26 August 2006)

  Urgent Medical Device Safety Information on BIOTRONIK Stratos LV-T Pacemakers (3 August 2006)

  Voluntary Field Corrective Action: Medtronic Model 7428 Kinetra Implantable Neurostimulator (20 July 2006)

  Voluntary Recall of Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps (14 July 2006)
 
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image 2005 copyright logo | Important notices Last revision date: 02 July 2009