Gentherm Medical, LLC recalls Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
- Recall date
- November 22, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0496-2022
- FDA classification
- Class II
- Brand / firm
- Gentherm Medical, LLC
- Sold / distributed
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
Why it was recalled
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
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