# FDA recall Z-0063-2019

> **Cincinnati Sub-Zero Products LLC, a Gentherm Company** · Class II · device recall initiated 2018-09-04.

## Product

Hemotherm 400CE, Catalog Numbers 86022 & 86023       The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

## Reason for recall

Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0063-2019
- **Recalling firm:** Cincinnati Sub-Zero Products LLC, a Gentherm Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-04
- **Report date:** 2018-10-10
- **Termination date:** 2019-05-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cincinnati, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0063-2019

## Citation

> AI Analytics. FDA recall Z-0063-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0063-2019. Source: US FDA. Licensed CC0.

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