Recall Z-3108-2017
CryoLife, Inc. · initiated February 12, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
Reason for recall
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-3108-2017
- Initiated
- February 12, 2014
- Terminated
- November 5, 2019
- Product code
- NPT – Aortic Valve, Prosthesis, Percutaneously Delivered
- Quantity
- 5 units
- Distribution
- US Distribution to the state of : Illinois
- Recalling firm
- CryoLife, Inc., Kennesaw, GA