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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