Recall of Blood-Pack Unit Whole Blood Filter, Fenwal Express System
DATE RECALL INITIATED: February 29, 2012
PRODUCT / LOT NUMBER:
Blood-Pack Unit Whole Blood Filter, Fenwal Express System, Product Code 4R3307E
- Lot Number: FM10F02019
Lake Zurich, IL
Fenwal has initiated a voluntary Urgent Product Recall of one lot (FM10F02019) of product code 4R3307E, Blood-Pack unit whole blood filter. Fenwal identified a labeling issue with the 4R3307E Blood-Pack unit in which the label for the satellite bag incorrectly identifies the product as Whole Blood. To date, there has only been a single reported occurrence. 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.
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.