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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Event Detail

Event ID 63695
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Svs. Indiana-Ohio Region
City Fort Wayne
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-28
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Michigan; Ohio; Indiana

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced Irradiated 038GP54798; Class II Blood products, collected using a machine for which the monthly quality control testing for platelet products failed, were distributed. 1 unit B-0453-13
Platelets Pheresis Leukocytes Reduced 038GP54750; 038GP54750; 038GP54756; 038GP54756; 038GP54772; 038GP54772; 038GP54775; 038GP54775; 038GP54779; 038GP54779; 038GP54779; 038GP54824; 038GP54824; 038GP54824; Class II Blood products, collected using a machine for which the monthly quality control testing for platelet products failed, were distributed. 14 units B-0454-13
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