DATE RECALL INITIATED:

August 23, 2018

PRODUCT / LOT NUMBER:

MANUFACTURER:

Haemonetics Manufacturing Inc.
Covina, California

REASON:

Haemonetics Corporation is voluntarily recalling 10 lots of their Leukotrap RC System with RC2D Filter (Reorder #129-62 and 129-63).

Haemonetics has received reports of higher than expected residual WBC associated with the lot numbers of Leukotrap RC Systems with RC2D Filter listed in the table. Haemonetics has identified that this issue arises from a manufacturing assembly issue related to a single RC2D filter lot (a subcomponent of the Leukotrap RC System).

Use of these lots may result in a higher than expected level of leukocytes in transfused blood.

Please discontinue the use of these lots and return any unused product to Haemonetics. Haemonetics will replace these recalled product lots. Contact your local customer service representative at the number below to coordinate the return and the shipment of replacement product to ensure a seamless exchange of goods.

Processed blood using these lots should not be re-filtered. Blood product processed by the affected lots and tested to have levels of leukocytes above recognized standards should be labeled as non-leukoreduced. Blood product already processed using the affected lots but that tested to have levels of leukocytes within recognized standards may still be labeled as leukoreduced.

The affected product lots were shipped to your firm between April 2018 and July 2018. This recall applies ONLY to the product IDs and lot numbers listed above. No other products or lots are affected by this action.

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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.