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  1. Safety & Availability (Biologics)

URGENT Recall Extension for Leukotrap RC System with RC2D Filter

URGENT Recall Extension for Leukotrap RC System with RC2D Filter

DATE RECALL INITIATED: June 20, 2016

PRODUCT:

All Lots of Leukotrap RC System with RC2D Filter (Re-Order Numbers 129-62 & 129-63)

(The affected product lots were distributed between April 14, 2016 and June 17, 2016)

MANUFACTURER:

Haemonetics Manufacturing Inc.
Covina, CA

REASON:

Haemonetics Corporation is voluntarily recalling All Lots of its Leukotrap RC System with RC2D Filter (Re-Order Numbers 129-62 & 129-63), distributed since April 14, 2016.

Haemonetics has received further reports of higher than expected residual WBC associated with lot numbers beyond those described in its June 8, 2016 recall notification.

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

Blood products that have been processed with these lots should not be re-filtered and should be labeled as non-leukoreduced, unless individual units have been tested and found suitable for such labeling. Continued use of these lots will require customers to verify that each unit labeled as leukoreduced was tested and meets standards for rWBC acceptable to FDA.

Customers wishing to return unused product to Haemonetics should contact their local customer service representative.


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.