Recall Z-1073-2019
CryoLife, Inc. · initiated January 17, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position.
Codes / lots: Model/Catalog Number ONXANE - 23, Lot number 6827216, Expiration Date 11/19/2024
Reason for recall
On-X Valve was mislabeled with the incorrect serial number.
FDA-determined cause: Employee error
Action taken
The affected customer was initially notified via email on 01/16/2019. A follow up notification explaining the reason for recall was provided via email on about 01/24/2019. Instructions included to quarantine and return the affected device.
Details
- Recall number
- Z-1073-2019
- Initiated
- January 17, 2019
- Terminated
- June 9, 2020
- Product code
- LWQ – Heart-Valve, Mechanical
- Quantity
- 2 devices
- Distribution
- Worldwide Distribution - US Nationwide - Georgia and Germany.
- Recalling firm
- CryoLife, Inc., Kennesaw, GA