CryoLife, Inc. recalls Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

Recall date

May 14, 2018

Source

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

Recall number

Z-2271-2018

FDA classification

Class II

Brand / firm

CryoLife, Inc.

Sold / distributed

AR, OH

Why it was recalled

Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.

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

What was recalled

Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO