medical Class II Updated 2022-01-19

Gentherm Medical, LLC recalls Electri-Cool II Portable Cold Therapy Unit, Model Number 767

Recalled Product

Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193


Hazard / Issue

This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)
View official government recall

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