FDA Device recall Z-0121-2019
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of CryoPatch SG Pulmonary Hemi-Artery, 1 graft by Cryolife, citing 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 l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0121-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-06 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cryolife |
| Distribution | US |
Product
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Reason
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.
Identifiers
| code_info | Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0121-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.