Electri-Cool II Portable Cold Therapy Unit recall: Labeling Error
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Why was Electri-Cool II Portable Cold Therapy Unit recalled?
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)
- Product
- Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
- Recalling firm
- Gentherm Medical, LLC
- Quantity
- 484 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
- Recall date
- January 19, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)