CryoPatch SG Pulmonary Hemi-Artery — Class II medical device recall Z-0121-2019
Terminated recall by CryoLife, Inc., reported 2018-10-24, distributed nationwide. The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The
| Recall number | Z-0121-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2018-09-06 |
| Classified | 2018-10-17 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2020-03-03 |
| Distributed | Nationwide (US) |
| Quantity | 1 graft |
| Reason classes | labeling |
| Lot numbers | 144125 |
| Serial numbers | 10978889 |
| Model numbers | SGPH00 |
| Expiration dates | 2022-05-16 |
Product
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0121-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.