CryoValve, Pulmonary Valve & Conduit
FDA device recall Z-0480-06 · posted 2006-02-04 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.
- Action taken
- Physicians were notified by letter on 1/27/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- NY
- Date initiated
- 2006-01-27
- Date posted
- 2006-02-04
- Date terminated
- 2006-04-04
- Location
- Kennesaw, GA
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