URGENT Recall for Leukotrap RC System with RC2D Filter
DATE RECALL INITIATED: June 8, 2016
PRODUCT / LOT NUMBER
|Product ID||Description||Lot #|
|129-62||Leukotrap RC System with RC2D Filter||1656076|
|129-63||Leukotrap RC System with RC2D Filter||1656083 and 1656084|
Haemonetics Manufacturing Inc.
Haemonetics Corporation is voluntarily recalling three lots of its Leukotrap RC System with RC2D Filter (Reorder #129-62 and 129-63).
Haemonetics has received reports of higher than expected residual WBC associated with lot numbers 1656076 (129-62) and 1656083 (129-63). Further, although they have not received reports, they have determined through their investigation that Reorder# 129-63, lot# 1656084 may also be affected by this issue and are recalling this lot as well.
Use of this lot may result in a higher than expected level of leukocytes in transfused blood. Blood products processed with these lots should not be re-filtered and should be labeled as non-leukoreduced.
Please discontinue the use of these lots and return any unused product to Haemonetics. Contact your local customer service representative to coordinate the return and the shipment of replacement product to ensure a seamless exchange of goods.
This recall applies ONLY to the product IDs and lot numbers listed above. No other products or lots are affected by this action.
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.