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Medical Device Safety
Medical Device Recalls
2011 Medical Device Recalls
2010 Medical Device Recalls
2009 Medical Device Recalls
2008 Medical Device Recalls
2007 Medical Device Recalls
2006 Medical Device Recalls
2001 - 2005 Medical Device Recalls
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2007 Medical Device Recalls
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2007 Medical Device Recalls
Listed by date posted by FDA
Device Name
Date
AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes)
12/20/07
Thoratec Corporation Implantable Ventricular Assist Devices (IVAD)
11/16/07
Welch Allyn AED 10™ Automatic External Defibrillators
11/02/07
Cardinal Health Alaris® Infusion Pump Module (formerly Medley™ Pump Module), Model 8100
10/29/07
Medtronic Inc. Sprint Fidelis® Defibrillator Leads
10/17/07
Baxa Corporation Exacta-Mix™ 2400 Operating Software Version 1.07 Pharmacy Compound System
09/27/07
Baxter Upgraded Colleague CX Single Channel Volumetric Infusion Pumps
09/25/07
MRL/Welch Allyn AED 20™ Automatic External Defibrillators
09/18/07
Sunrise Medical Quickie® Power Wheelchairs
08/17/07
Advanced Medical Optics, Inc. COMPLETE® MoisturePLUS™ Multi-purpose Contact Lens Solution
08/01/07
Baxter Healthcare Corp. COLLEAGUE® and FLO-GARD® Volumetric Infusion Pumps (Updated August 8, 2007)
07/27/07
Thoratec® Paracorporeal Ventricular Assist System (PVAD)
07/26/07
Thoratec® TLC-ll® Portable Ventricular Assist Device (VAD) Driver
07/26/07
Baxter Healthcare Corp. Upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps
07/20/07
Bayer Ascensia® Contour® Blood Glucose Monitoring System
07/13/07
Integra LifeSciences Corporation (also known as Integra NeuroSciences) EnDura™ No-React® Dural Substitute
05/31/07
Ortho-Clinical Diagnostics, Inc. VITROS® Immunodiagnostic Products Troponin I Reagent Pack
05/22/07
Abbott Laboratories Inc. ARCHITECT® STAT Troponin-I Immunoassay
06/08/07
Alcon Refractive Horizons, Inc. LADAR6000 (TM) Excimer Laser System
06/04/07
Smith & Nephew, Inc. Radiofrequency Denervation Probes
03/27/07
HoMedics® Thera-P® Heating Pads
03/19/07
LifeLine® Semi-Automatic External Defibrillators (AEDs) and ReviveR® Semi-Automatic External Defibrillators (AEDs)
03/07/07
Counterfeit OneTouch® Ultra® Blood Glucose Test Strips
01/14/07
Counterfeit OneTouch® Basic®/Profile® Blood Glucose Test Strips
01/14/07
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