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Device Correction of Baxter Amicus Separator

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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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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

 
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