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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 63569
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross, Penn-Jersey Region
City Philadelphia
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-07
Initial Firm Notification of
Consignee or Public		 FAX
Distribution Pattern Pennsylvania; New Jersey

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced Irradiated 22FL28810PART1; 22FL28810PART2; 22FL28699PART2; Class II Blood products, collected using equipment that had not been validated, were distributed. 3 units B-0396-13
Platelets Pheresis Leukocytes Reduced 22FL28725PART1; 22FL28725PART2; 22FL28699PART1; 22FL28679PART1; Class II Blood products, collected using equipment that had not been validated, were distributed. 4 units B-0397-13
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