CryoValve, Pulmonary Valve and Conduit
FDA device recall Z-0669-05 · posted 2005-04-06 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
- Action taken
- Consignee was notified by letter on 01/12/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- KS
- Date initiated
- 2005-01-12
- Date posted
- 2005-04-06
- Date terminated
- 2005-04-12
- Location
- Kennesaw, GA
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