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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

Product Description Red Blood Cells Leukocytes Reduced Irradiated
Recall Number B-1528-12
Classification Class III
Code Info 033FY66023; 033FY66024; 033FY66025; 033FY66026; 033FY66027; 033FY66028; 033FY66029; 033FY66030; 033FY66031; 033FY66032; 033FY66033; 033FY66034; 033FY66035; 033FY66037; 033FY66038; 033FY66039; 033FY66040; 033FY66041; 033FY66013; 033FY66014; 033FY66015; 033FY66016; 033FY66017; 033FY66018; 033FY66019; 033FY66020; 033FY66021; 033FY66022; 033FY66047; 033FY66048; 033FY66049; 033FY66050; 033FY66051; 033FY66042; 033FY66043; 033FY66044; 033FY66045; 033FY66046;
Product Distributed Qty 38 units
Reason For Recall Blood products, collected using equipment for which quality control was not performed, were distributed.

Event Detail

Event Id 61783
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Services
City Farmington
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-13
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern Connecticut; New York