Gentherm Medical, LLC Recall 89193
Description: Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Gentherm Medical, LLC Recall 89193 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0496-2022 |
| Event ID | 89193 |
| Event Description | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE. |
| Quantity | 484 devices |
| Recall Reason | This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads. |
| Device Classification | 20220119 |
| Device Code Info | UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694) |
| Center Classification Date | 20220113 |
| Recall Initiation Date | 20211122 |
| Recalling Firm | Gentherm Medical, LLC |
| Initial Notification | Letter |
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