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U.S. Department of Health and Human Services

Medical Device Recalls

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Product Description
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DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a de... 3 Dec-22-2015 BC Group International Inc
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT D... 3 Nov-23-2015 Biochemical Diagnostics Inc
Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; ... 3 Nov-20-2015 Lab Vision Corporation
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis ... 3 Nov-17-2015 Baxter Healthcare Corp.
MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coo... 3 Nov-10-2015 CooperSurgical, Inc.
AMSCO 400 and AMSCO C Small Steam Sterilizers 3 Nov-04-2015 Steris Corporation
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the... 3 Nov-04-2015 Becton, Dickinson and Company, BD Biosciences
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units 3 Nov-02-2015 C.R. Bard, Inc.
VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Id... 3 Nov-02-2015 Ortho-Clinical Diagnostics
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the per... 3 Oct-15-2015 Alere San Diego, Inc.

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