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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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HeartWare Ventricular Assist System (HVAD).
Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, ...
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1
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06/11/2015
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HeartWare Inc
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M/L Taper with Kinectiv® Technology.
prosthesis, hip, semi-constrained (metal uncemented acetabular...
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1
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06/08/2015
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Zimmer, Inc.
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HeartWare Ventricular Assist System (HVAD).
Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,11...
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1
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06/08/2015
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HeartWare Inc
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FLOW-i Anesthesia System
The FLOW-i Anesthesia System is intended for use administering inhalatio...
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1
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06/08/2015
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Maquet Cardiovascular Us Sales, Llc
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Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, produ...
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1
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05/29/2015
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Synovis Surgical Innovations, Inc.
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CareFusion AVEA ventilator, all models.
Product Usage:
A continuous ventilator (respirator), int...
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1
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05/26/2015
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Carefusion 211 Inc dba Carefusion
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HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit
Product Usage:
Is intended ...
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1
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05/14/2015
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HeartWare Inc
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TIGERPAW System II,
Part number C-TP-1507 (7 connector)
The TigerPaw System II is an implantabl...
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1
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04/23/2015
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Laax, Inc.
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TIGERPAW System II,
Part number C-TP-1509 (9 connector)
The TigerPaw System II is an implantabl...
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1
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04/23/2015
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Laax, Inc.
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OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufacture...
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1
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04/23/2015
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OriGen Biomedical, Inc.
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