CryoLife, Inc. recalls CryoPatch SG Pulmonary Hemi-Artery, 1 graft
- Recall date
- September 6, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0121-2019
- FDA classification
- Class II
- Brand / firm
- CryoLife, Inc.
- Sold / distributed
- US Nationwide in the state of California.
Why it was recalled
The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
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, 1 graft
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