# FDA recall Z-0372-2022

> **Cardinal Health** · Class II · device recall initiated 2021-11-02.

## Product

Cardinal Health Poly-Reinforced Surgical Gowns Large  SKU: 9010

## Reason for recall

Potential for open packaging seals compromising the sterility of the surgical gowns

## Distribution

Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada,  Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

## Key facts

- **Recall number:** Z-0372-2022
- **Recalling firm:** Cardinal Health
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-02
- **Report date:** 2021-12-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0372-2022

## Citation

> AI Analytics. FDA recall Z-0372-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0372-2022. Source: US FDA. Licensed CC0.

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