Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Gentherm Medical, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

Product Codes/Lot Numbers:

UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0496-2022

Related Recalls

There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.

Jun 17, 2021 Other Medical Devices Nationwide View Details →