Enforcement Report - Week of August 29, 2012
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Event Detail
| Event ID | 62305 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | SightLife |
| City | Seattle |
| State | WA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-01 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | One cornea was shipped to each of 2 physicians in Japan. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Corneas | AAG744ODCN; AAG744OSCN | Class II | Human Corneas, recovered from a donor with evidence of infection due to a communicable disease agent, were distributed. | 2 corneas, (1 right, 1 left) | B-2312-12 |
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