CryoValve, Aortic Valve
FDA device recall Z-1134-04 · posted 2004-07-22 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired.
- Action taken
- The physicians were notified by letter on 07/01/2004. Both tissues were reported implanted.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- CA, TX
- Date initiated
- 2004-07-01
- Date posted
- 2004-07-22
- Date terminated
- 2004-09-03
- Location
- Kennesaw, GA
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