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.
Other recalls by Cryolife
- BioGlue Surgical Adhesive, Model BG3510-5-G
FDA Device · Class II · 2021-12-22 · Cryolife - CryoPatch SG Pulmonary Human Cardiac Patch
FDA Device · Class II · 2020-12-30 · Cryolife - CryoValve SG Pulmonary Human Heart Valve
FDA Device · Class II · 2020-12-30 · Cryolife - On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseas…
FDA Device · Class II · 2019-04-03 · Cryolife - CryoPatch SG Pulmonary Hemi-Artery, 1 graft
FDA Device · Class II · 2018-10-24 · Cryolife
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1219-2019%22
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