CryoValve Aortic Valve
FDA device recall Z-0854-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- A retrospective review of donor files conducted by CryoLife revealed an expired solution had been used during processing of the associated tissues.
- Action taken
- Consignees were notified by letter on 03/02/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- CA
- Date initiated
- 2004-02-25
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-14
- Location
- Kennesaw, GA
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