# FDA recall Z-0211-2022

> **Z-Medica, LLC** · Class II · device recall initiated 2021-09-22.

## Product

QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding  Model / Part# 200

## Reason for recall

Lack of Packaging seal integrity may result in a sterile barrier breach.

## Distribution

US Nationwide distribution in the state of NC.

## Key facts

- **Recall number:** Z-0211-2022
- **Recalling firm:** Z-Medica, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-22
- **Report date:** 2021-11-17
- **Termination date:** 2024-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wallingford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0211-2022

## Citation

> AI Analytics. FDA recall Z-0211-2022. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-0211-2022. Source: US FDA. Licensed CC0.

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