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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 49951
Product Type Biologics
Status Terminated
Recalling Firm ZLB Bioplasma, Inc.
City Lexington
State KY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-08-22
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern IL, Germany, and Switzerland.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Source Plasma 0530546029, 0530545681, 0530542822, 0530542328, 0530540867, 0530540564, 0530539531, 0530539185, 0530537708, 0530536769, 0530536312, 0530533622, 0530533283, 0530532387, 0530531990, 0530530965, 0530530556, 0530529630, 0530529182, 0530528280, 0530526014, 0530525450, 0530521176, and 0530520099. Class II Blood products, collected from a donor whose physical was overdue, were distributed. 24 units B-2313-13
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