CryoLife product recalled over labeling errors

Recall date

January 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CryoLife, Inc. recalls On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the r…

Recall number

Z-1073-2019

FDA classification

Class II

Brand / firm

CryoLife, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide - Georgia and Germany.

Why it was recalled

On-X Valve was mislabeled with the incorrect serial number.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.