CryoValve, Pulmonary Valve and Conduit
FDA device recall Z-1593-05 · posted 2005-10-01 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit.
- Action taken
- Consignee was notified by letter on 01/26/2004. The tissue was returned to CryoLife and destroyed.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- CA
- Date initiated
- 2004-01-26
- Date posted
- 2005-10-01
- Date terminated
- 2005-10-06
- Location
- Kennesaw, GA
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