Enforcement Report - Week of January 16, 2013
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Product Detail
| Product Description | Tendon, Human Tissue allograft; TranZgraft (brand for TBI); Product is prepared and distributed by TBI/Tissue Banks International, San Rafael, CA |
|---|---|
| Recall Number | B-0163-13 |
| Classification | Class I |
| Code Info | CL1202013007; CL1202013008; CL1202013009; CL1202013010; CL1202013003 |
| Product Distributed Qty | 5 |
| Reason For Recall | Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. |
Event Detail
| Event Id | 63120 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Tissue Banks International |
| City | San Rafael |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-31 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Allograft products were released for distribution to 6 consignees in US. located in CA, MD and PA. |
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