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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced
Recall Number B-1309-13
Classification Class II
Code Info 49KP13657 (2 units), 49KP13659, 49KP13661 (2 units), 49KP13663 (3 units), 49KP13666 (2 units), 49KP13669 (2 units), 49KP13671, 49KP13677, 49KP13681, 49KP13684 (2 units), 49KP13687, 49KP13691, 49KP13692, 49KP13695, 49KP13699, 49KP13708 (3 units), 49KP13704 (3 units), 49KP13713, 49KP13722, 49KP13724, 49KP13726, 49KP13728, 49KP13730, 49KP13732, 49KP13736 (2 units), 49KP13739 (2 units)
Product Distributed Qty 39 units
Reason For Recall Blood products, which were labeled as leukoreduced, but were collected on an apheresis machine that failed quality control testing for leukoreduction, were distributed.

Event Detail

Event Id 56466
Product Type Biologics
Status Completed
Recalling Firm American National Red Cross (The)
City Tulsa
State OK
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-06-29
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern OK, CA, TX, IN
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