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Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of
Recalled November 27, 2019 · FDA recall Z-0419-2020 · Cincinnati Sub-Zero Products LLC, a Gentherm
Hazard
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 · FDA Class II
Units
5291
Sold at
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.
Description
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
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.
Manufacturer(s)
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →