# FDA recall Z-0653-2021

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

## Product

CryoPatch SG Pulmonary Human Cardiac Patch.  The patch 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 patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below  135¿ C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.

## 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-0653-2021
- **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-0653-2021

## Citation

> AI Analytics. FDA recall Z-0653-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-0653-2021. Source: US FDA. Licensed CC0.

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