# FDA recall Z-1219-2019

> **CryoLife, Inc.** · Class II · device recall initiated 2016-11-21.

## Product

CryoPatch SG Pulmonary Hemi-Artery Patch

## Reason for recall

The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.

## Distribution

Product was shipped to Texas

## Key facts

- **Recall number:** Z-1219-2019
- **Recalling firm:** CryoLife, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-11-21
- **Report date:** 2019-05-01
- **Termination date:** 2019-09-24

- **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-1219-2019

## Citation

> AI Analytics. FDA recall Z-1219-2019. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1219-2019. Source: US FDA. Licensed CC0.

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