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Vaccines, Blood & Biologics

Device Correction of Baxter Amicus Separator-Baxter Healthcare Corp

DATE RECALL INITIATED:

March 16, 2005

PRODUCT / LOT NUMBER:

AMICUS SEPARATOR

Product Codes 4R4580 and 4R4580R
All Serial Numbers

MANUFACTURER:

Baxter Healthcare Corporation
Deerfield, Illinois

REASON:

Baxter has redesigned the AMICUS SEPARATOR Instrument centrifuge window to withstand ammonia cleaning; however it is Baxter's recommendation that ammonia and ammonia based cleaners NOT be used to clean any part of the AMICUS SEPARATOR Instrument. Instead, a mild soap/detergent is recommended. Baxter will replace the AMICUS SEPARATOR Instrument centrifuge window on all AMICUS SEPARATOR Instruments.

 

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(240) 402-8010
Consumer Affairs Branch (CBER)

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Office of Communication, Outreach and Development

Food and Drug Administration

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Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 06/25/2013
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