FDA Recall
Terminated
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
Recall: Z-3108-2017
·
Initiated February 12, 2014
Recall
- Recall Number
- Z-3108-2017
- Event Number
- 77728
- Firm
- CryoLife, Inc.
- FEI Number
- 3001451326
- Product Code
- NPT
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 12, 2014
- Terminated
- November 5, 2019
- Address
- 1655 Roberts Blvd NW, Kennesaw, GA, 30144-3632
Description
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
Reason
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Action
On February 12, 2014, it was discovered that five devices were processed under the wrong RGA number This is a retrospective reporting. Three units were collected and returned to the firm, while two were implanted. For further questions, please call ( 770) 419-3355.
Distribution
US Distribution to the state of : Illinois
Quantity
5 units