# FDA recall Z-0069-2022

> **CardioQuip, LLC** · Class II · device recall initiated 2021-06-24.

## Product

CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.

## Reason for recall

There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices  which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of TX, PA, FL, CA, HI, SC, OH, AK, NY, IL, AR, WI, MI, AL, KS, NJ, GA, AZ, KY, MS, TN, LA, DE, MA, VA, CO, NE, NC, NH, ME, WV, PA, MO, MN, IN, CT, NH, NV, UT and the country of Venezuela.

## Key facts

- **Recall number:** Z-0069-2022
- **Recalling firm:** CardioQuip, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-24
- **Report date:** 2021-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** College Station, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2022

## Citation

> AI Analytics. FDA recall Z-0069-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0069-2022. Source: US FDA. Licensed CC0.

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