Class 2 Device Recall ElectriCool II Portable Cold Therapy Unit

• Date Initiated by Firm: November 22, 2021
• Create Date: January 13, 2022
• Recall Status: Terminated on May 08, 2023
• Recall Number: Z-0496-2022
• Recall Event ID: 89193
• Product Classification: Pack, hot or cold, water circulating - Product Code ILO
• Product: Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
• Code Information: UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)
• Recalling Firm/ Manufacturer: Gentherm Medical, LLC; 12011 Mosteller Rd Fl 3; Blue Ash OH 45241-1528
• Manufacturer 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.
• FDA Determined 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 in Commerce: 484 devices
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.