Enforcement Report - Week of February 27, 2013
-
Back to Previous Page
Product Detail
| Product Description | Vascular Graft |
|---|---|
| Recall Number | B-0768-13 |
| Classification | Class II |
| Code Info | 9887377; 9887385; 9887396; 9887480 |
| Product Distributed Qty | 4 |
| Reason For Recall | Human Tissues, recovered from a donor whose donor eligibility determination did not identify if the donor was free from risk factors for and clinical evidence of, infection due to relevant communicable disease agents, were distributed. |
Event Detail
| Event Id | 64210 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | CryoLife, Inc. |
| City | Kennesaw |
| State | GA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-12 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Tennessee; Missouri; Kentucky; Texas |
-
