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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced Irradiated 49KP13681, 49KP13684, 49KP13687 (2 units), 49KP13705 (2 units), 49KP13715 (2 units), 49KP13717 (3 units), 49KP13720, 49KP13724, 49KP13728, 49KP13735, 49KP13736, 49KP13738, 49KP13671 Class II Blood products, which were labeled as leukoreduced, but were collected on an apheresis machine that failed quality control testing for leukoreduction, were distributed. 18 units B-1308-13
Platelets Pheresis Leukocytes Reduced 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) Class II Blood products, which were labeled as leukoreduced, but were collected on an apheresis machine that failed quality control testing for leukoreduction, were distributed. 39 units B-1309-13
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