Recall Z-0496-2022— Gentherm Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Gentherm Medical, LLC, initiated 2021-11-22, terminated 2023-05-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193. Reason: This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads..
- Recalling firm
- Gentherm Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-22
- Terminated
- 2023-05-08
- Firm location
- Blue Ash, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.