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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Source Plasma
Recall Number B-0716-13
Classification Class III
Code Info 380098221, 380091801, 380095082, 380102319, 380093481, 380113918, 380106427, 380096985, 3800003417, 380100217, 380100491, 380111162, 380106940, 380107283, 380108885, 380111205, 380104488, 380105322, 380103028, 380098015, 380106785, 380099826, 380095696, 380092908, 380091944, 380108728, 380092169, 3800049989, 380111054, 380106540, 380104691, 380105648, 380097869, 3800024783, 380113213, 380114842, 380112449, 380104240, 380097106, 380107764, 380108063, 380111541, 38011917, 380100306, 3800007683, 380100117,380120861, 380114378, 380113395, 380112672, 380107722, 3800007855, 3800011972, 3800013705, 3800016966, 380112192, 380112456, 380113203, 380114527, 380107768, 380109650, 380109901, 380111431, 380106685, 3800014815, 3800011631, 3800011977, 3800016720, 3800018904, 3800023822, 3800025939, 3800032229, 380100438, 380113307, 3800012543, 380102704, 380102364, 380096979, 380093172, 380093149, 3800050812, 3800021421, 3800025602, 3800026282, 3800027849, 3800029571, 380120851, 380105380, 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Product Distributed Qty 7066 units
Reason For Recall Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

Event Detail

Event Id 54058
Product Type Biologics
Status Terminated
Recalling Firm Talecris Plasma Resources Inc
City Research Triangle Park
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-09-01
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern North Carolina
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