CryoValve, Pulmonary Heart Valve
FDA device recall Z-0065-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection.
- Action taken
- The implanting physician was notified by letter on 9/25/2003. The tissue was reported implanted therefore notification was intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed stamped postcard was enclosed to affirm receipt of notification.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- The tissue was distributed to one physician in CA.
- Date initiated
- 2003-09-25
- Date posted
- 2003-10-24
- Date terminated
- 2004-05-06
- Location
- Kennesaw, GA
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