Synergraft CryoValve, Aortic Valve & Conduit SG
FDA device recall Z-0528-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Microorganisms were detected in associated tissue.
- Action taken
- Consignees were notified by letter on 1/16/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- CA, MI,OK
- Date initiated
- 2004-01-16
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-03
- Location
- Kennesaw, GA
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