# FDA recall Z-0121-2019

> **CryoLife, Inc.** · Class II · device recall initiated 2018-09-06.

## Product

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

## Reason for recall

The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling.  The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.

## Distribution

US Nationwide in the state of California.

## Key facts

- **Recall number:** Z-0121-2019
- **Recalling firm:** CryoLife, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-06
- **Report date:** 2018-10-24
- **Termination date:** 2020-03-03

- **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-0121-2019

## Citation

> AI Analytics. FDA recall Z-0121-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0121-2019. Source: US FDA. Licensed CC0.

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