DATE RECALL INITIATED: February 29, 2012
PRODUCT / LOT NUMBER:
Blood-Pack Unit, Product Code 4R3459
- Lot Number: FM11J03027
Lake Zurich, IL
Fenwal has initiated a voluntary Urgent Product Recall of one lot (FM11J03027) of product code 4R3459, Blood-Pack unit. ;Fenwal identified an assembly issue with the 4R3459 Blood-Pack Unit in which the satellite bag used for the storage of platelets was PL146 instead of the expected PL2209 plastic bag. ;The PL146 is used for the storage of platelets for three (3) days, whereas the correct bag and label for product 4R3459 is indicated for the storage of platelets for five (5) days. ;To date, there has only been one reported occurrence of a mislabeled bag. ;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.