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U.S. Department of Health and Human Services

Medical Device Recalls

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Date Classified to: 05/08/2014 PMA Number: P110013/S005
 
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The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005... 2 Jan-23-2015 Synthes, Inc.
Multi-Lumen PI CVC Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015... 2 Jan-22-2015 Arrow International Inc
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis... 2 Jan-22-2015 Arrow International Inc
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usag... 2 Jan-22-2015 Aptalis Pharmatech Inc.
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct imm... 2 Jan-20-2015 BD Biosciences, Systems & Reagents
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1... 3 Jan-20-2015 Ortho-Clinical Diagnostics
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometri... 2 Jan-20-2015 BD Biosciences, Systems & Reagents
PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIF... 2 Jan-20-2015 Genetic Testing Institute,inc
Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington... 2 Jan-20-2015 Dick's Sporting Goods
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-... 2 Jan-16-2015 Cordis Corporation

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