Enforcement Report - Week of September 19, 2012
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Product Detail
| Product Description | South Dakota Lions Eye Bank, Cornea, SD11-079, For single use only, Not considered sterile, Culturing Recommended. |
|---|---|
| Recall Number | B-2313-12 |
| Classification | Class II |
| Code Info | SD11079OD; SD11079OS |
| Product Distributed Qty | 2 |
| Reason For Recall | Human Corneas, recovered from a donor who had not been properly evaluated, were distributed. |
Event Detail
| Event Id | 62304 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | South Dakota Lions Eye and Tissue Bank, Inc. |
| City | Sioux Falls |
| State | SD | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-27 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | NC, Egypt |
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