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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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

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.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Building 71 Room 3103

Silver Spring, MD 20993-0002