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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Blood Component Infusion Set (Product Code: 4C2223)

DATE RECALL INITIATED: October 4, 2011

 
PRODUCT:

Product Code 4C2223, Blood Component Infusion Set
80 Micron Blood Component Filter Female Luer
 
MANUFACTURER:
 
Fenwal, Inc.
Lake Zurich, Illinois
 
REASON:
 
Fenwal identified a labeling issue with the 4C2223 Blood Component Infusion Set in which the package label incorrectly states 80 Micron filter when the actual filter size is a standard blood filter of 170-260 micron in size. Fenwal is recommending that customers immediately discontinue the use of this product and return the 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.