# FDA recall Z-2140-2021

> **Maquet Medical Systems USA** · Class II · device recall initiated 2021-07-14.

## Product

Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

## Reason for recall

There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

## Distribution

Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.

## Key facts

- **Recall number:** Z-2140-2021
- **Recalling firm:** Maquet Medical Systems USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-14
- **Report date:** 2021-08-04
- **Termination date:** 2022-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2140-2021

## Citation

> AI Analytics. FDA recall Z-2140-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2140-2021. Source: US FDA. Licensed CC0.

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