CryoValve, Aortic Valve and Conduit
FDA device recall Z-0581-05 · posted 2005-03-10 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Records noted that the infant donor's mother had tested positive for Hepatitis B.
- Action taken
- Physicians were notified by letter on 12/17/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- CA, FL
- Date initiated
- 2004-12-17
- Date posted
- 2005-03-10
- Date terminated
- 2006-01-27
- Location
- Kennesaw, GA
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