Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | Cornea |
|---|---|
| Recall Number | B-0378-13 |
| Classification | Class III |
| Code Info | 20111263; 20111264 |
| Product Distributed Qty | 2 |
| Reason For Recall | Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
Event Detail
| Event Id | 63562 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Transplant Services Center UT Southwestern Medical Center |
| City | Dallas |
| State | TX | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-16 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Texas |
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