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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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Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1
Product Us...
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2
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11/11/2015
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Philips Electronics North America Corporation
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MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS.
Enables the perfusionist to manage the patient's...
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2
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09/04/2015
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Medtronic Perfusion Systems
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MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72...
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2
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09/04/2015
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Medtronic Perfusion Systems
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Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)
Int...
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2
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09/04/2015
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Mindray DS USA, Inc. dba Mindray North America
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ADVIA Centaur® Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877.
Used to prepare the Red Bl...
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2
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09/04/2015
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Siemens Healthcare Diagnostics, Inc
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2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-S...
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2
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09/04/2015
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Trilliant Surgical Ltd.
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OmniPod® Insulin Management System. Only the OmniPod® device is affected. Catalog Number(s): POD-ZXP...
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1
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09/04/2015
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Insulet Corporation
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OmniPod® Insulin Management System. Only the OmniPod® device is affected. Catalog Number(s): 14810 ...
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1
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09/04/2015
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Insulet Corporation
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Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determi...
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2
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09/03/2015
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Beckman Coulter Inc.
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Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV --
Product Usage:
to measure flow intra-operat...
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2
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09/03/2015
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Transonic Systems Inc
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