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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 - FM10J08050

 

DATE RECALL INITIATED: February 29, 2012

 
PRODUCT / LOT NUMBER:
 
Blood-Pack Unit with Flex-Excel Red Cell Filter, Product Code 4R1583
Lot Number FM10J08050
 
MANUFACTURER:
 
Fenwal, Inc.
Lake Zurich, IL
 
REASON:
 
Fenwal has initiated a voluntary Urgent Product Recall of one lot (FM10J08050) of product code 4R1583,
Blood-Pack unit with Flex-Excel red cell filter. Fenwal identified a labeling issue with one batch of Product code 4R1583 in which the label for the whole blood collection container incorrectly identifies the contents as leukoreduced red cells. To date, there is only one reported occurrence of this incident. No safety concerns have been raised, however Fenwal is recommending that customers immediately check their inventory, discontinue the use of this product, and return any remaining 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.