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 contact manufacturer or local supplier for details. (Updated on 5 March 2010).
| Summary for the Current Year |
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| Summary for Previous Years |
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Medtronic Physio-Control LIFEPAK 15 (5 March 2010) |
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Novacare Alternating pressure mattress overlay (ASX) (4 March 2010) |
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StatSpin (IRIS Sample Processing) StatSpin Express 4 Centrifuges (Model #510) (1 March 2010) |
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Stryker Instruments Navigation System II CART / PC SPC-1 (18 February 2010) |
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Pointe Scientific Liquid Glucose (HEXO) Reagent Set - 814301, 820502, 823901, 826801, 829401, 814301, 820502, 831502 (18 February 2010) |
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Philips Healthcare Allura Xper Systems / Allura Integris Systems with Velara Generator (17 February 2010) |
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Baxter HomeChoice Automated PD System / HomeChoice PRO Automated PD (17 February 2010) |
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Acacia IV Extension Sets with BD Q-Syte Luer Access Device (REF: 385150, 385151, 385164, 385165, 385166) (10 February 2010) |
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BD BD Q-Syte Luer Access (Cat no. 380510, 385100, 385101) and BD Nexiva Closed IV Catheter Systems (Cat. No. 383530, 383531, 383532, 383533, 383534, 383536, 383537, 383538, 383539,383540,383647,383649) (10 February 2010) |
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Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning System Version 3.0, 3.1, 3.5.0, 3.5.1) (9 February 2010) |
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Covidien Moltech/Accutronics Battery (Rev. D & E) used in Legendair and Supportair ventilators and Associated Accessory-Open Pack (9 February 2010) |
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Cardiac Science Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, CardioLife 9200G and 9231 (manufactured/serviced between Oct 19, 2009 and Jan 15, 2010) (8 February 2010) |
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Thomas Medical Products Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport (5 February 2010) |
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Dana Douglas A) Nexus 1, B) Nexus 2 (4 February 2010) |
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Centurion Healthcare Products (code no. LM110, LM115) (4 February 2010) |
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Philips Switched Reusable Internal Defibrillation Paddles (Product Numbers M4741A, M4742A, M4743A and M4744A) (2 February 2010) |
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Inion CPS baby screw (REF: SCR-1221, Lot no. 0809009 and 0809069) (1 February 2010) |
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Edwards Lifesciences Aquarius Hemodialysis System (Model no. GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04) (29 January 2010) |
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Exelint Exelint Exel/Exelint Huber needles (Code: 26901, 26902, 26904, 26906, 26907, 26908, 26909, 26911, 26921, 26922, 26923, 26924, 26925), Exel/Exelint Huber Infusion Sets (Code: 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 27954R, 27955R, 27958R, 27959R) and Exel/Exelint ˇ§Securetouch+ˇ¨ Safety Huber Infusion Sets (Code: 37854S, 37855S, 37858S) (27 January 2010) |
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Hettich Plastic Hematocrit Rotors - 201424-01 Haematokrit 20 with 2050 haematocrit rotor, 2004-01 Mikro 20 with 2076 haematocrit rotor, 2070 Mikro 12-24 with 2050 haematocrit rotor, 2075 Haematokrit 24 with 2050 haematocrit rotor - (25 January 2010) |
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Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning System Version 3.5) (25 January 2010) |
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Philips Heartstart FRx AED (861304) and Heartstart HS1 Onsite Defrillator (M5066A) (22 January 2010) |
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Merit Medical Systems Mistique Infusion Catheters (14 January 2010) |
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ev3 Trailblazer Support Catheter (Model no. SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150) (6 January 2010) |
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Biosense Webster (a JNJ company) NaviStar RMT Diagnostic/Ablation Steerable Tip Catheters (22 December 2009) |
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Biomet Vanguard lock-on femoral impactor 32-486206 (22 December 2009) |
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Biosense Webster (a JNJ company) Carto 3 System (10 December 2009) |
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Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs (8 December 2009) |
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Medtronic Legend AF01 Footed Attachment (8 December 2009) |
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Immucor Galileo Echo Blood Bank Analyzer (8 December 2009) |
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STERIS System 1 Processor (SS1) (7 December 2009) |
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Nipro Europe Pureflux Dialyser (PF-210L) (4 December 2009) |
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St Jude Medical Epicor Ultrawand LP (4 December 2009) |
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Fresenius Kabi Agilia Volumat Administration Sets VLON90 (4 December 2009) |
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Cordis CROSSOVER Sheath Introducer Cat. No. 403545S, 403585S, 403645S, 403685S, 403745S, 403785S (28 November 2009) |
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Cardiovascular Systems ViperSheath Sheath Introducer (18 November 2009) |
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Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices (16 November 2009) |
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Smith & Nephew Endo Femoral Aimers (9 November 2009) |
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Synthes Ti Synex II Vertebral Body Replacement (VBR) (13 November 2009) |
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ConMed Linvatec MC5057 Universal Cable (13 November 2009) |
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ConMed Linvatec PowerPro, PowerProMax and Mpower handpieces (13 November 2009) |
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Maquet Servo Ventilators Models SV300 and SV900 (13 November 2009) |
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Edwards Lifesciences CardioVations EndoClamp Aortic Catheter Models EC1001 and EC65 (12 November 2009) |
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URIT Uritest 13G urine test strips (6 November 2009) |
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Unomedical Manual Pulmonary Resuscitators (13 October 2009) |
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Philips HeartStart FR2 M3860A/M3861A, M3840A/M3841A (29 Sept 2009) |
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Medtronic Concerto CRT-D and Virtuoso ICD (8 Sept 2009) |
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Welch Allyn AED 10 and MRL JumpStart Defibrillators (21 July 2009)  |
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Boston Scientific LeVeen Needle Electrodes - 5.0cm (10 July 2009) |
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Medtronic QUICK-SET INFUSION SETS Models MMT-396, MMT-397, MMT-398 and MMT-399 (10 July 2009) |
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Medtronic Model 8551 SynchroMed Refill Kits w/ reversed UBD and Mfg Dates (10 July 2009) |
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Boston Scientific Flexima and Percuflex drainage catheter family (pigtail style, peripheral interventions), Percuflex and percutaneous model drainage catheter family (urology) (10 July 2009) |
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BD 60ml Lurt-Lok Syringes (Recorder Number 309653; Lot No.: 819101A) (9 July 2009) |
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Respironics BiPAP Focus Noninvasive Ventilator System (9 July 2009) |
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Boston Scientific Flexima Biliary Catheter System (8 July 2009) |
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Medtronic SynchroMed II (Model 8637) Implantable Drug Infusion Pump Battery Performance (6 July 2009) |
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Bausch & Lomb Boston Conditioning Solution Original Formula (2 July 2009) |
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