Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The…

Recall date

July 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0417-2020

FDA classification

Class II

Brand / firm

Cincinnati Sub-Zero Products LLC, a Gentherm Company

Sold / distributed

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,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.