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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description Platelets Pheresis Leukocytes Reduced Irradiated
Recall Number B-1293-13
Classification Class II
Code Info 011LS57296;011LS57296;011LS57303;011LS57311; 011LS57324;011LS57324;011LS57311;011LS57296; 011LS57354;011LS57354
Product Distributed Qty 10 Units
Reason For Recall Blood products, collected using equipment that had not been validated, were distributed.

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