Vaccines, Blood & Biologics

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.


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.