CryoValve, Pulmonary Valve & Conduit
FDA device recall Z-0298-05 · posted 2004-12-08 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- CryoLife received information stating that the tissue donation was deferred due to possible Hepaititis C suspected by the MD.
- Action taken
- Consignee was notified verbally on 07/28/2004. The Allograft was retrieved and discarded.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- MI
- Date initiated
- 2004-07-28
- Date posted
- 2004-12-08
- Date terminated
- 2004-12-17
- Location
- Kennesaw, GA
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