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Recall of Sepacell PLS-5A Platelet Leukoreduction Filter with Administration Set, Platelet Bedside Filter

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DATE RECALL INITIATED:

    March 15, 2005

PRODUCT / LOT NUMBER:

    Platelet Bedside Filter

    Product Code Number - 4C2496
    Lot Number - A04I08265

MANUFACTURER:

    Baxter Healthcare Corporation
    Deerfield, Illinois

REASON:

    Baxter has determined that the pre-filter on Platelet Bedside Filter sets were assembled in the inverted orientation. Consignees have been asked to contact the manufacturer to arrange for product return.

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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.

 

Updated May 4, 2005
 
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