CryoValve, Aortic Valve and Conduit
FDA device recall Z-0686-05 · posted 2005-04-06 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- An incorrect lot number was entered in the production record for the solution in which this allograft was packaged.
- Action taken
- Consignee was notified by letter on 12/02/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- TN
- Date initiated
- 2004-12-02
- Date posted
- 2005-04-06
- Date terminated
- 2010-06-28
- Location
- Kennesaw, GA
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