FDA Device recall Z-1219-2019
CryoPatch SG Pulmonary Hemi-Artery Patch
- FDA Device
- Class II
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class II recall of CryoPatch SG Pulmonary Hemi-Artery Patch by Cryolife, citing 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 cl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1219-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-21 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cryolife |
| Distribution | TX |
Product
CryoPatch SG Pulmonary Hemi-Artery Patch
Reason
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.
Identifiers
| code_info | Model #: SGPHOO Serial #10685466 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1219-2019%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.