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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 57227
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Services
City Saint Louis
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-09-21
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Missouri; Texas; Kentucky

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced Irradiated 011LS57296;011LS57296;011LS57303;011LS57311; 011LS57324;011LS57324;011LS57311;011LS57296; 011LS57354;011LS57354 Class II Blood products, collected using equipment that had not been validated, were distributed. 10 Units B-1293-13
Platelets Pheresis Leukocytes Reduced 011LS57298; 011LS57298; 011LS57298; 011LS57301; 011LS57301; 011LS57301; 011LS57303; 011LS57308; 011LS57311; 011LS57315; 011LS57315; 011LS57319; 011LS57324; 011LS57330; 011LS57349; 011LS57358; 011LS57358; 011LS57330; 011LS57324; 011LS57319; 011LS57354; 011LS57308; 011LS57349; 011LS57338; 011LS57363; 011LS57361; 011LS57330 Class II Blood products, collected using equipment that had not been validated, were distributed. 27 Units B-1294-13
Red Blood Cells Leukocytes Reduced 011LS57368; 011LS57364; 011LS57327; 011LS57338 Class II Blood products, collected using equipment that had not been validated, were distributed. 4 Units B-1295-13
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