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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Event Detail

Event ID 58357
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (the)
City Charlotte
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-01-27
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern NC

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fresh Frozen Plasma 012LV66409, 012LV66410, 012LV66417, 012LV66418, 012LV66422, 012LV66425 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 6 units B-1714-13
Red Blood Cells Leukocytes Reduced 012LV66398, 012LV66403, 012LV66405, 012LV66408, 012LV66409, 012LV66410, 012LV66413, 012LV66414, 012LV66417, 012LV66418, 012LV66419, 012LV66421, 012LV66422, 012LV66424, 012LV66425, 012LC66429 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 16 units B-1713-13
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