medical Class II Updated 2019-11-27

Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Blanketrol II Hyper-Hypothermia System, Models 222R and 222

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model 222R (071-18490 through 123-20534) Model 222S (104-2-00001 through 161-2-01848)
View official government recall

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