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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of AMICUS Ancillary PL2410 Plastic Storage Container 4R2350

Recall of  AMICUS Ancillary PL2410 Plastic Storage Container 4R2350


DATE RECALL INITIATED:

March 29, 2010

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Lot FA10A26035
Expiration January 31, 2010

MANUFACTURER:

Baxter Fenwal Division
Dominican Republic

REASON:

Fenwal is notifying customers of an urgent product recall that they implemented on March 26, 2010.  The affected product, 4R2350, lot number FA10A26035 is an ancillary platelet storage container used with the Amicus Separator disposable kit.  Fenwal has received reports of leaks on the seals at the end of the tubing leads used to connect to the Amicus disposable kit.  Root cause has been identified and corrective actions implemented.

Due to a potential breach in sterility, Fenwal recommends that you immediately discontinue use of this lot.  Additionally, any platelet products stored using this lot, or from the same collection, should not be used.
Customers are asked to contact the manufacturer to arrange for product return.


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.