FDA Recall
Terminated
CryoValve Heart-valve, allograft
Recall: Z-0723-03
·
Initiated March 19, 2003
Recall
- Recall Number
- Z-0723-03
- Event Number
- 25832
- Firm
- Cryolife Inc
- FEI Number
- 3001451326
- Product Code
- LMO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 19, 2003
- Posted
- April 15, 2003
- Terminated
- May 5, 2003
- Address
- 1655 Roberts Blvd Nw, Kennesaw, GA, 30144
Description
CryoValve Heart-valve, allograft
Reason
The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
Action
Implanting physicians were notified by letter on 3/19/2003. Since CryoLife has been notified that the allografts have been implanted, the notification is intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. They were advised to complete an enclosed, stamped, self-addressed postcard to affirm receipt of the notification.
Distribution
Allografts were distributed to 2 physicians in NY and MS. Allografts were implanted.
Quantity
There are two individual heart valve allografts.