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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Event Detail

Event ID 62546
Product Type Biologics
Status Terminated
Recalling Firm LifeSource
City Rosemont
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-25
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Illinois; Pennsylvania; Switzerland

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced Irradiated W287911005810; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 unit B-2459-12
Platelets Pheresis W287611005669; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 unit B-2460-12
Platelets Pheresis Leukocytes Reduced W286912002963; W286912002963; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 2 units B-2461-12
Red Blood Cells W288412002489; W288311002985; W286911003931; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 3 units B-2462-12
Platelets W287911005810; W288412002489; W288311002985; W286911003931; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 4 units B-2463-12
Plasma Frozen within 24 hours (FP24) W287911005810; W288412002489; W288311002985; W286911003931; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 4 units B-2464-12
Red Blood Cells Leukocytes Reduced W288412002706; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 unit B-2465-12
Blood and Blood Products for Reprocessing W288412002706; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 unit B-2466-12
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