CryoPatch SG Pulmonary Hemi-Artery Patch — Class II medical device recall Z-1219-2019
Terminated recall by CryoLife, Inc., reported 2019-05-01, distributed in TX. The device is recalled due to donor ineligibility of released human tissue. The firm received information that
| Recall number | Z-1219-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2016-11-21 |
| Classified | 2019-04-25 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2019-09-24 |
| Distributed | TX |
| Quantity | 1 |
| Serial numbers | 10685466 |
Product
CryoPatch SG Pulmonary Hemi-Artery Patch
Reason for recall
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.
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-1219-2019. 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.