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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Blood-Pack Unit with Flex-Excel Red Cell Filter

 

DATE RECALL INITIATED: February 29, 2012
 
PRODUCT / LOT NUMBER:
 
Blood-Pack Unit with Flex-Excel Red Cell Filter, Product Code 4R1582
Lot Numbers: FM11E17034, FM11G11017, FM11G18012
 
MANUFACTURER:
 
Fenwal, Inc.
Lake Zurich, IL
 
REASON:
 
Fenwal has initiated a voluntary Urgent Product Recall of three lots (FM11E17034, FM11G11017, and FM11G18012) of product code 4R1582, Blood-Pack unit with Flex-Excel red cell filter. Fenwal identified a labeling issue with three batches of Product code 4R1582 in which the label for the leukoreduced red cell storage container incorrectly identified the contents as non-leukoreduced red cells. To date, there are only three reported occurrences of this incident; one incident on each lot. No safety concerns have been raised, however Fenwal is recommending that customers immediately check their inventory, discontinue the use of this product, and return the impacted product to Fenwal.
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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.