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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 39644
Product Type Biologics
Status Terminated
Recalling Firm New York Blood Center, Inc.
City New York
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2005-02-03
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern New Jersey, California, New York, Switzerland

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Plasma for Further Manufacturing 6238935, 6238909, 6238785, 6238937,6238945, 6238958 Class III Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 6 B-0786-13
Red Blood Cells Irradiated 6238945 Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 1 B-0785-13
Fresh Frozen Plasma 6238918, 6238913, 6238900, 6238883, 6238820, 6238816, 6238859, 6238873, 6238848, 6238843. Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 10 B-0784-13
Platelets 6238918, 6238913, 6238909, 6238900, 6238820, 6238816, 6238873, 6238848 and 6238843. Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 9 B-0783-13
Red Blood Cells Leukocytes Reduced 6238820, 6238843, 6238848, 6238859, 6238873, 6238883 6238900, 6238913,, and 6238918. Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 9 B-0782-13
Red Blood Cells 6238785, 6238816, 6238935, 6238937 and 6238958. Class II Blood products, collected from donors in which donor suitability was not adequately determined, were distributed. 5 B-0781-13
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