CryoValve SG Pulmonary Human Heart Valve — Class II medical device recall Z-0652-2021
Terminated recall by CryoLife, Inc., reported 2020-12-30, distributed nationwide. On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for ot
| Recall number | Z-0652-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2020-11-10 |
| Classified | 2020-12-21 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2021-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 00877234000447 |
| Serial numbers | 11682491, 11685214, 11685554 |
| Model numbers | SGPV00 |
Product
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135¿C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.
Reason for recall
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
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-0652-2021. 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.