# FDA recall Z-0652-2021

> **CryoLife, Inc.** · Class II · device recall initiated 2020-11-10.

## 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.

## Distribution

Distributed nationwide to GA, AZ, TX, MO, and OK.

## Key facts

- **Recall number:** Z-0652-2021
- **Recalling firm:** CryoLife, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-10
- **Report date:** 2020-12-30
- **Termination date:** 2021-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kennesaw, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0652-2021

## Citation

> AI Analytics. FDA recall Z-0652-2021. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0652-2021. Source: US FDA. Licensed CC0.

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