CryoValve Pulmonary Valve and Conduit
FDA device recall Z-0548-04 · posted 2004-02-25 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.
- Action taken
- The consignee was notified by letter on 12/10/2003. CryoLife received confirmation of receipt of the notification from the physician who reported the tissue was implanted on 04/17/1997.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- The allograft was shipped to one physician in TX.
- Date initiated
- 2003-12-10
- Date posted
- 2004-02-25
- Date terminated
- 2004-07-23
- Location
- Kennesaw, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.