# FDA recall Z-0036-2022

> **CardioQuip, LLC** · Class II · device recall initiated 2021-05-12.

## Product

CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127

## Reason for recall

Labeling does not include guidance for  proper water-quality maintenance and device inspection for heater cooler devices.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.

## Key facts

- **Recall number:** Z-0036-2022
- **Recalling firm:** CardioQuip, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-12
- **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-0036-2022

## Citation

> AI Analytics. FDA recall Z-0036-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0036-2022. Source: US FDA. Licensed CC0.

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