# FDA recall Z-0419-2020

> **Cincinnati Sub-Zero Products LLC, a Gentherm Company** · Class II · device recall initiated 2019-07-02.

## Product

CoolBlue Hyper-Hypothermia System- body hypothermia system  Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

## Reason for recall

Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

## Distribution

Worldwide distribution - US Nationwide and countries of   Afghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada  Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait,   Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands,   New Zealand, Oman, Pakistan, Palestine, Panama,   Philippines, Qatar, Saudi Arabia, Singapore, South Africa,   South Korea, Spain, Taiwan, Thailand, Trinidad and Tobago,  Turkey, United Arab Emirates, Venezuela, Vietnam.

## Key facts

- **Recall number:** Z-0419-2020
- **Recalling firm:** Cincinnati Sub-Zero Products LLC, a Gentherm Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-02
- **Report date:** 2019-11-27
- **Termination date:** 2020-06-22

- **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-0419-2020

## Citation

> AI Analytics. FDA recall Z-0419-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0419-2020. Source: US FDA. Licensed CC0.

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