FDA Enforcement
Class II
Terminated
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Recall: Z-0496-2022
·
Reported January 19, 2022
Enforcement
- Recall Number
- Z-0496-2022
- Event ID
- 89193
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Gentherm Medical, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 19, 2022
- Initiation Date
- November 22, 2021
- Classification Date
- January 13, 2022
- Termination Date
- May 8, 2023
- Address
- 12011 Mosteller Rd Fl 3, N/A, Blue Ash, OH, 45241-1528, United States
Description
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.
Code Info
UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
Quantity
484 devices