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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.

 

 

Contact FDA

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(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Suite 200N/HFM-47

Rockville, MD 20852-1448
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