FDA Medical Device Recalls (openFDA)
Gentherm Medical, LLC: Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
- Recall number
- Z-0496-2022
- Recalling firm
- Gentherm Medical, LLC
- Product
- Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
- Status
- Terminated
- Initiated
- 2021-11-22
- Posted
- not on file
- Terminated
- 2023-05-08
- Reason
- This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
- Root cause
- Device Design
- Action
- URGENT Medical Device Recall notification letters dated 11/19/21 were sent to customers. Pad Instructions: 1. Read and understand operation manual before connecting paCI to Etectri-Cool II. 2. Read and understand pad application instructions accompanying GENTHERM pad. 3. Connect hose to unit by inserting connectors on hose into connectors on unit. Connectors should "click" as they lock together. 4. Apply pad to patient and attach pad to hose by inserting connectors on pad into hose connectors. Normal use of the pad is to be applied in direct contact with the patient. Pad may be used over or under a patient, in the flat state or wrapped around patient. 5. Turn unit "ON" and set to temperature. 6. After pad has filled, check water level in unit. Add sterile water or water that has been passed through a filter less than or equal to 0.22 microns, only if necessary. 7. When therapy needs to be paused, disconnect the pad from the Electri-Cool II and allow the unit to continue to run. NOTE: Reconnect the pad when ready to resume therapy. 8. When therapy is no longer needed disconnect pad from hose by pressing metal clips. Dispose of pad. 9. Tum unit "OFF" at the power switch and unplug the power cord from the outlet. INSTRUCTIONS TO CUSTOMERS: 1) Immediately examine your inventory and add this letter and/or Appendix B to Electri-Cool II manual. 2) Ensure that all users are informed of the contents of this letter. If you have further distributed this product, please provide those accounts with a copy of this notice. 3) Please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform Gentherm Medical, LLC that you have performed and completed the requested actions. Return the form by e-mail to FA2021-012@gentherm.com, or mail to: Gentherm Medical, LLC 12011 Mosteller Road Cincinnati, OH 45241 This recall should be carried out to the user level. Your assistance is appreciated and necessary to reduce potent
- Quantity
- 484 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
- Lot, serial or model codes
- UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILO
- Firm FEI
- 1516825
- Firm city
- Blue Ash
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28