Reported Jan 19, 2022 · Terminated
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Gentherm Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Gentherm Medical, LLC · 12011 Mosteller Rd Fl 3 · Blue Ash, OH · 45241-1528
Is this the product you have?
Electri-Cool II Portable Cold Therapy UnitModel Number 767Part Number 86193
- Lot codes and dates
- UDI- 10613031861938
- Affected Serial Numbers are(164-76703084 Through 213-76703694)
- Amount recalled
- 484 devices
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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