FDA Device recall Z-2271-2018
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
- FDA Device
- Class II
- terminated
- Published 2018-06-27
On 2018-06-27 the FDA classified a Class II recall of Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO by Cryolife, citing devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2271-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-14 |
| Published | 2018-06-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cryolife |
| Distribution | AR, OH |
Product
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Reason
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Identifiers
| code_info | Serial Number 10988203 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Cryolife
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FDA Device · Class II · 2020-12-30 · Cryolife - CryoValve SG Pulmonary Human Heart Valve
FDA Device · Class II · 2020-12-30 · Cryolife - CryoPatch SG Pulmonary Hemi-Artery Patch
FDA Device · Class II · 2019-05-01 · 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
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2271-2018%22
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