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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description Source Plasma
Recall Number B-2195-12
Classification Class III
Code Info 4270048655, 4270047980, 4270047086, 4270046540, 4270045902, 4270044950, 4270044614, 4270044149, 4270043875, 4270042392, 4270042054, 4270041511, 4270040729, 4270040476, 4270039910, 4270039604, 4270038051, 4270037444, 4270034510, 4270034756, 4270035549, 4270036211, 4270036424, 4270033296, 4270033874, 4270037101, 4270032362, 4270025109, 4270031713, 4270032690, 4270029598, 4270029850, 4270030688, 4270030976, 4270027551, 4270029059
Product Distributed Qty 36 units
Reason For Recall Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.

Event Detail

Event Id 59515
Product Type Biologics
Status Terminated
Recalling Firm Octapharma Plasma, Inc.
City Charlotte
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-07-01
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern CA, Austria
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