2010 年度召回總清單(List of Device Recalls)

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2010 年度召回總清單(List of Device Recalls)

FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.
Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The links give details about what to do if you own or use one of these products.
Please note that FDA now lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. You can find the date that a firm initiated a recall in the text of the recall notice.
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2010 Medical Device Recalls
Listed by date posted on FDA website
Device Name
Date
Penumbra System Reperfusion Catheter 032
12/08/10
Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps - Recall, Refund and Replacement
11/30/10
B. Braun addEASE Binary Connector
11/30/10
WalkMed, Inc. Triton Pole Mount Infusion Pump
11/24/10
Micromedics, Inc., Surgical Sealant Dispensers, Micromedics Nasal Septal Buttons, and Otological Ventilation Tubes – Sealed in Pouches
11/23/10
SIGMA Spectrum Infusion Pump Model 35700
11/12/10
bioMérieux, Inc., VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP)
11/10/10
Hospira Symbiq One and Two Channel Infuser
11/04/10
Medtronic Octopus Nuvo Tissue Stabilizer, Model TSMICS1
11/02/10
Excelsior Medical Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL syringe)
10/26/10
CareFusion Corporation, Alaris PC Units (Model 8015)
10/15/10
Westmed Inc., BagEasy Manual Resuscitation Devices
10/13/10
Multi-Med, Inc. Huber (Non-coring) Needles and Finished Devices Containing Huber Needles Labeled as "All-Med Medical Products, Inc." and "Marquette Medical, Inc." Brands and Provided to Some Consignees in Bulk Without Labeling
10/12/10
Symbiq One and Two-Channel Infusers
09/21/10
AngioScore Inc. - AngioSculpt "EX" PTCA Scoring Balloon Catheter
09/08/10
Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls)
08/26/10
Ikaria Holdings, INOMAX DS Drug Delivery System
08/23/10
St. Jude Medical 6 French Engage™ Introducer Devices
08/13/10
Cook Medical - Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube
08/04/10
Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System
07/20/10
Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser
07/15/10
Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System
07/02/10
Physio-Control Inc., LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors
07/02/10
Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED™ and Lifeline AED® Semi-automatic External Defibrillators
06/14/10
Counterfeit Polypropylene Surgical Mesh Products Marketed as C. R. Bard/Davol
06/10/10
GE Healthcare Aisys and Avance Anesthesia Systems
05/17/10
Certain Cuffed Shiley Tracheostomy Tubes
05/17/10
Cardiac Science Corporation, Powerheart, CardioVive, Nihon Kohden, and GE Responder Automated External Defibrillators (AEDs)
04/30/10
Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator
04/22/10
Teleflex Incorporated - Arrow International Custom Intravenous (IV) Administration Products (IV Tubing Sets and Accessories) and Certain Arrow Arterial Embolectomy Catheters
04/08/10
Four Class I Recalls: Becton, Dickinson (BD) and Company, Q-Syte Luer Access Split Septum and Numerous Products Containing the Q-Syte Luer Access Split Septum Repackaged and Distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.
03/30/10
Gyrus ACMI, Inc. Micron Bobbin Vent Tube T, 1.27 mm
03/17/10
Baylis Medical Company Inc., Torflex Transseptal Guiding Sheath
03/11/10
Beckman Coulter Inc., UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell
03/10/10
Abiomed, Inc., AB5000 Circulatory Support System
03/10/10
Cardiac Science Corporation - Powerheart, Cardiovive, NK, and Responder Automated External Defibrillators (AEDs)
03/08/10
Thomas Medical Products Inc., Transseptal Sheath Introducer Kits
03/08/10
Baxter HomeChoice and HomeChoice PRO
03/03/10
Exelint International Inc. - Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch+" Safety Huber Infusion Sets
02/26/10
StatSpin, Inc., doing business as IRIS Sample Processing, StatSpin Express 4 Centrifuges, Model #510
02/26/10
Thomas Medical Products Inc., Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport
02/04/10
Hettich Instruments Management I, Hettich Centrifuges with 2050 and 2076 Plastic Rotors
01/28/10
Edwards Lifesciences Inc., Aquarius Hemodialysis System
01/28/10
ev3 Endovascular, Inc., Trailblazer Support Catheter
01/05/10
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Additional Resources
Medical Device Recalls
Recalls Database
Alerts and Notices (Devices)
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
FDA 101: Product Recalls - From First Alert to Effectiveness Checks