FDA-Device2017-09-13Class II
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.
CryoLife, Inc.
Hazard
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Sold states
US Distribution to the state of : Illinois
Affected count
5 units
Manufactured in
1655 Roberts Blvd NW, N/A, Kennesaw, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3108-2017Don't want to check this manually?
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