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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Event Detail

Event ID 57465
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Ashley
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-10-29
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern PA, NY

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells (Apheresis) Leukocytes Reduced 30LM02557 (Parts 1 and 2) Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 2 units B-1750-13
Red Blood Cells 30GV71814, 30FN33298, 30FW61951, 30FW62308, 30GZ19273 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 5 units B-1749-13
Red Blood Cells Leukocytes Reduced 30GV71292, 30GV71597, 30GX30904, 30GX32297, 30FN31824, 30FN31831, 30FN32575, 30FN34189, 30GT60367, 30GT60470, 30GT60478, 30GT60484, 30GV69491, 30GV69638, 30GX32685, 30GX32718, 30GX32738, 30GX32923, 30GX32957, 30GY87076, 30GY87106 Class II Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed. 21 units B-1748-13
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