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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Event Detail

Event ID 62362
Product Type Biologics
Status Terminated
Recalling Firm HCSC-Blood Center
City Bethlehem
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-21
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Pennsylvania, Korea, New Jersey

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Recovered Plasma W050912012863 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 unit B-2345-12
Red Blood Cells Leukocytes Reduced W050912012863, W050912013540 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 2 units B-2346-12
Fresh Frozen Plasma W050912009254 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 unit B-2347-12
Red Blood Cells W050912010131 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 unit B-2348-12
Platelets Pheresis Leukocytes Reduced W050912013552 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 1 unit B-2349-12
Red Blood Cells Leukocytes Reduced W050912011703, W050912009254 Class III Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 2 units B-2350-12
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