Home / Recalls / Gentherm Medical, LLC / Z-0496-2022

Z-0496-2022 Class II Terminated

Recalled by Gentherm Medical, LLC — Blue Ash, OH

Recall Details

Product Type: Devices
Report Date: January 19, 2022
Initiation Date: November 22, 2021
Termination Date: May 8, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 484 devices

Product Description

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

Reason for Recall

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

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.

Code Information

UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)