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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Event Detail

Event ID 63474
Product Type Biologics
Status Terminated
Recalling Firm Blood Centers of the Pacific - Irwin Center
City San Francisco
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-05
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern California

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced Irradiated W117012518302Q; W117012518302Q; Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed. 2 B-0290-13
Platelets Pheresis Leukocytes Reduced W117012326743U; W117012326743U; W117012326743U; W117011507369G; W117011507369G; W1170114535114; Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell counts, were distributed. 6 B-0291-13
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