CryoValve Heart Valve
FDA device recall Z-1188-03 · posted 2003-08-29 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.
- Action taken
- Consignees were notified by letter sent on various dates starting April, 2003 and were advised to provide the disposition of the tissue to CryoLife.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 325 units
- Distribution
- Tissues were distributed to hospitals and physicians located nationwide and worldwide.
- Date initiated
- 2003-04-01
- Date posted
- 2003-08-29
- Date terminated
- 2004-10-21
- Location
- Kennesaw, GA
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