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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Event Detail

Event ID 46538
Product Type Biologics
Status Terminated
Recalling Firm Community Blood Bank of Lancaster County Medical Society
City Lincoln
State NE
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-12-04
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern Austria; FL; NE

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Platelets Pheresis Leukocytes Reduced 3754793;3754792 Class III Blood products, which Viral Testing performed, interpreted, or documented incorrectly, were distributed. 2 units B-2356-12
Red Blood Cells Leukocytes Reduced 8011980 Class III Blood products, which Viral Testing performed, interpreted, or documented incorrectly, were distributed. 1 unit B-2355-12
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