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 29 July 2010).
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[3 July 2010] Cepheid Xpert Flu A Panel (GXFLUPANEL-10, GXFLUPANEL-CE-10) (Lot Numbers: 00401, 00502, 00701, 00702, 00501) |
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[19 June 2010] Ace Surgical Supply Calcium Sulfate Hemihydrate Kit, 1g (Model or Catalog#505-2001) and Calcium Sulfate Hemihydrate Kit, 0.5g (Model or Catalog#505-2002) |
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[19 June 2010] Remington Disposable Surgical Extension Cable (Model or Catalog#
FL-601-97, Lot or Serial# 100701)
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[19 June 2010] Smith & Nephew Genesis II Resection Cutting Blocks (Model or Catalog # 71440116, 71440118) |
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[10 June 2010] Sorin Paradym DR, CRT-D & CRT-D sonR ICD (Models:8550, 8750 & 8770) |
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[9 June 2010] C.R. Bard/Davol Counterfeit flat sheets of polypropylene surgical mesh labeled with C.R. Bard/Davol brand names (product no. 0112650, 0112660, 0112680, 0112720 Bard Flat Mesh with lot no. 48HVS036, 43APD007, HUSD0629, HURL0336, 43HPD027, 43HPD032, 43HPD034, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011, 43IPD038, 43FQD327) are not Bard-manufactured products |
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[1 June 2010] Philips HeartStart FR2+ Automated External Defibrillator |
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[31 May 2010] Medtronic LIFEPAK 20 and LIFEPAK 20e Defibrillator/Monitors |
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[28 May 2010] Stryker AVS (Adaptive Vertebral PEEK Spacer) TL Spacer Trial 7-18 (Product Ref: from 48389407 to 48389418) |
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[20 May 2010] Terumo Sarns Disposable Centrifugal Pump (Cat. Nos. 164275 & 16427X) and Cardiovascular Procedure Kits containing pumps from affected lots |
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[18 May 2010] Defibtech DBP-2800 Battery Packs used with DDU-100 series AEDs sold under the brand names Lifeline AED and ReviveR AED (serial no.: between 202001005 and 202005916, or between 206001001 and 206009871) |
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[13 May 2010] Philips Heartstart FRx AED (Model 861304), Heartstart (HS1) Onsite AED (Model M5066A), Heartstart (HS1) Laerdal brand onsite AED (Model M5067A), HeartStart HS1 Defibrillator (Model M5068A) |
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[12 May 2010] Heartware Ventricular Assist System Controller |
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[11 May 2010] GE Healthcare CARESCAPE Monitor B850 version 1.0.1.13 and 1.0.2.1 |
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[7 May 2010] Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570) |
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[7 May 2010] Varian Varisource iX Console |
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[7 May 2010] Cook Medical Ciaglia Blue Dolphin and Ciaglia Blue Rhino Balloon Percutaneous Tracheostomy Introducer Set (with Shiley Percutaneous Tracheostomy Tube) |
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[6 May 2010] St. Jude Medical Convert+ Model V-195 Implantable Cardioverter-Defibrillator |
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[6 May 2010] Beckman Coulter Synchron Systems Modular Glucose (GLUCm) Reagent (Model 472500) |
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[6 May 2010] Codman & Shurtleff (JNJ) Medstream Implantable Drug Pump (Model: 91-4200, 91-4201) |
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[5 May 2010] Philips Heartstart MRx Defibrillator Monitors |
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[5 May 2010] Baxter Colleague Volumetric Infusion Pump |
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[5 May 2010] Medtronic Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK), Maximo II DR/VR (D284DRC, D284VRC) |
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[21 April 2010] Covidien Shiley tracheostomy products (lot no. in the range of 0810XXXXXX to 0908XXXXXX) |
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[21 April 2010] Cyberonics VNS Therapy Model 250 Programming Software (version 7.1) for demipulse and demipulse duo generators |
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[15 April 2010] Animas A) 2020 Insulin Pump, B) OneTouch Ping Insulin Pump (Model : A) 100-380-51, 100-381-51, 100-382-51, 100-384-51, 100-385-51, 200-260-51, 200-261-51, 200-262-51, 200-263-51, 200-264-51, 200-265-51, 200-370-00, 200-371-00, 200-372-00, 200-374-00, 200-375-00, B) 100-420-51, 100-421-51, 100-422-51, 100-424-51, 100-425-51, 100-430-51, 100-431-51, 100-432-51, 100-434-51, 100-435-51) |
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[15 April 2010] Precision Medical Flow Selector (Model : PM1000) |
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[15 April 2010] Fresenius Medical Care Disinfection block (spare part) for 5008 & 5008S dialysis system |
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[15 April 2010] Kimal Long Term Haemodialysis Catheters |
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[13 April 2010] BrainLAB iPlan RT Dose software versions 4.0, 4.1.0 and 4.1.1 (Model No. 21213C, 21213D and 21213E) used with Monte Carlo Dose Algorithm 23071 |
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[12 April 2010] ArjoHuntleigh Minstrel patient hoist (non scale type) |
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[9 April 2010] ConMed Electrosurgery Goldline Rocker Switch Pencil (Cat. # 130301A, 130304A, 130307A, 130319A, 130327A, 130337A, 130339A, 131307A, 131319A, 131327A, 60-6829-001A, 60-6829-005A) |
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[31 March 2010] Recall of IMGHC-TX, IMGHC-MX, IMGHC-LS silicone-filled breast implant manufactured by POLY IMPLANT PROTHESE (PIP) |
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[31 March 2010] GE Healthcare Trusat Oximeter and Trusat Oximeter With Expension Option |
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[29 March 2010] Lancer Fibro Cleaner Automatic Endoscope Reprocessors FC4 |
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[29 March 2010] Varian FastPlan Conical Collimator Plans |
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[29 March 2010] Abbott Diagnostics ARCHITECT Anti-HCV Reagents List numbers: 6C37-20, 6C37-25 and 6C37-30 |
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[26 March 2010] Biotest Medical Diagnostics Seraclone Anti-k (KEL2) |
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[25 March 2010] Centurion Medical Products Pump Fill Kit DT10175 |
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[18 March 2010] Arrow International (Teleflex Medical) MAC Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device (Catalog/Part # ASK-21242-UVA2), Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath (Catalog/Part # ASK-29803-SJH), Multi-Lumen Central Venous Catheterization Kit with Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-42703-SJH), Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-42802-SHB), Multi-Lumen Central Venous Catheterization Kit with Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-45703-SHB), Multi-Lumen Central Venous Catheterization Kit with Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-45703-UVA2) |
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[18 March 2010] Medical Action Industries Bundle Kit, using MPS Acacia with Q-Syte BD#385151 (Cat. no. 69946B), Venous Access Tray, using BD Q-Syte Luer Access Split Septum BD #385100 (Cat. no. 69498), Dialysis Kit, using BD Q-Syte Luer Access Split Septum BD #385100 (Cat. no. 57977) |
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[18 March 2010] Gyrus Medical Micron Bobbin Vent Tube T, 1.27 mm, Catalog (REF) Number 145281-ENT, Lot Number MH136952 |
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[17 March 2010] Nova Medical Nova Statstrip Glucose Test Strips (lot no. 0309019249) |
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[17 March 2010] Unomedical (Convatec) Unilect ECG Electrodes |
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[16 March 2010] GE Healthcare 1011-9000-000 Aisys Anesthesia Machine and Monitor, 1009-9002-000 Avance Anesthesia Machine and Monitor |
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[16 March 2010] Teleflex Medical Arrow Select IV Tubing Sets, Accessories, and Certain Embolectomy Catheters |
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[12 March 2010] Baylis Medical Torflex Transseptal Guiding Sheath (Model no. TF8-38-62-S, Lot no. S21244, S21903, S21940, S22739, and S22739X1) |
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[11 March 2010] Beckman Coulter UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell. UniCel DxC 600 (PN No. A10405), 600 PRO (A11810), 600i (A27318), 800 (A11816), 800 PRO (A11812), 880i (A59102), 680i (A64903), 660i (A64871), 860i (A64935) |
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[11 March 2010] Abiomed AB5000 Circulatory Support System (Cat. No. 0015-0000, Serial No. AD5001 through AD5496 except AD5006 & AD5018) |
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[9 March 2010] Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; CardioVive 92531, 92532, 92533; NK 9200G, 9231; Responder 2019198 and 2023440 |
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[8 March 2010] Thomas Medical Products Transseptal Sheath Introducer Kit (also under the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit) |
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[5 March 2010] Medtronic Physio-Control LIFEPAK 15 |
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[4 March 2010] Novacare Alternating pressure mattress overlay (ASX) |
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[1 March 2010] StatSpin (IRIS Sample Processing) StatSpin Express 4 Centrifuges (Model #510) Stryker Instruments Navigation System II CART / PC SPC-1 [18 February 2010] |
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[18 February 2010] Pointe Scientific Liquid Glucose (HEXO) Reagent Set - 814301, 820502, 823901, 826801, 829401, 814301, 820502, 831502 |
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[17 February 2010] Philips Healthcare Allura Xper Systems / Allura Integris Systems with Velara Generator |
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[17 February 2010] Baxter HomeChoice Automated PD System / HomeChoice PRO Automated PD |
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[10 February 2010] Acacia IV Extension Sets with BD Q-Syte Luer Access Device (REF: 385150, 385151, 385164, 385165, 385166) |
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[10 February 2010] 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) |
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[9 February 2010] Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning System Version 3.0, 3.1, 3.5.0, 3.5.1) |
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[9 February 2010] Covidien Moltech/Accutronics Battery (Rev. D & E) used in Legendair and Supportair ventilators and Associated Accessory-Open Pack |
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[8 February 2010] Cardiac Science Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, CardioLife 9200G and 9231 (manufactured/serviced between Oct 19, 2009 and Jan 15, 2010) |
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[5 February 2010] Thomas Medical Products Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport |
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[4 February 2010] Dana Douglas A) Nexus 1, B) Nexus 2 |
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[4 February 2010] Centurion Healthcare Products (code no. LM110, LM115) |
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[2 February 2010] Philips Switched Reusable Internal Defibrillation Paddles (Product Numbers M4741A, M4742A, M4743A and M4744A) |
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[1 February 2010] Inion CPS baby screw (REF: SCR-1221, Lot no. 0809009 and 0809069) |
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[29 January 2010] Edwards Lifesciences Aquarius Hemodialysis System (Model no. GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04) |
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[27 January 2010] 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 “Securetouch+” Safety Huber Infusion Sets (Code: 37854S, 37855S, 37858S) |
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[25 January 2010] 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 - |
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[25 January 2010] Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning System Version 3.5) |
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[22 January 2010] Philips Heartstart FRx AED (861304) and Heartstart HS1 Onsite Defrillator (M5066A) |
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[14 January 2010] Merit Medical Systems Mistique Infusion Catheters |
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[6 January 2010] 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) |
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