CryoValve Pulmonary Valve & Conduct
FDA device recall Z-0167-04 · posted 2003-11-27 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.
- Action taken
- Consignee was notified by letter on 11/4/2003. The tissue was reported implanted on 10/14/2003. The letter was intended to provide the hospital with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed, stamped postcard was enclosed to verify receipt of notification.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- One unit
- Distribution
- The tissue was shipped to one hospital in MO.
- Date initiated
- 2003-11-04
- Date posted
- 2003-11-27
- Date terminated
- 2004-05-06
- Location
- Kennesaw, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.