Z-0496-2022 Class II Terminated
FDA device recall Z-0496-2022 was initiated by Gentherm Medical, LLC on November 22, 2021 and is designated Class II. 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. The recall status is terminated (terminated May 8, 2023). Affected quantity: 484 devices.
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)