Recall Z-0496-2022 ยท ILO Pack, Hot Or Cold, Water Circulating
Gentherm Medical, LLC
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
| Date | Nov 22, 2021 |
| Status | Terminated |
| 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 |
| Quantity | 484 devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.