CryoLife product recalled over labeling errors

Recall date

June 12, 2015

Source

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

Official notice title

CryoLife, Inc. recalls On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native…

Recall number

Z-2715-2017

FDA classification

Class II

Brand / firm

CryoLife, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN. and the countries of Finland, United Kingdom and Israel

Why it was recalled

Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.

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 Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions