Z-0496-2022Class II

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

Name: Z-0496-2022 Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Creator: Gentherm Medical, LLC
Published: 2021-11-22
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2021-11-22 / Terminated / root cause: design

FDA source

Gentherm Medical, LLC began a recall of Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 on 2021-11-22. FDA classified it as Class II and gives the reason as "This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0496-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-22
Posted: 2022-01-13
Terminated: 2023-05-08
Recalling firm: Gentherm Medical, LLC
Product: Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Product code: ILO Pack, Hot Or Cold, Water Circulating
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.
Root cause tag: design
FDA 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 [email protected], 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 in commerce: 484 devices
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
Product codes and lots: UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0496-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0496-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-13

Product code ILO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)