Cincinnati Sub-Zero Products LLC, a Gentherm Company: 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

Agency Publication Date: November 18, 2019

Affected Products

Product: Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

Serial Numbers: 071-3-00123 through193-3-09498

Product: Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

Model 222R (071-18490 through 123-20534) Model 222S (104-2-00001 through 161-2-01848)

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.

Serial Numbers: 073-CB-00001 through 162-CB-00294

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83464

Status: Resolved

Manufacturer: Cincinnati Sub-Zero Products LLC, a Gentherm Company

Manufactured In: United States

Units Affected: 3 products (3932; 3726; 5291)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.