CryoLife, Inc. recalls CryoPatch SG Pulmonary Hemi-Artery Patch

Recall date

November 21, 2016

Source

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

Recall number

Z-1219-2019

FDA classification

Class II

Brand / firm

CryoLife, Inc.

Sold / distributed

Product was shipped to Texas

Why it was recalled

The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.

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

What was recalled

CryoPatch SG Pulmonary Hemi-Artery Patch