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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2271-2018%22
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