BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0496-2022 · Initiated November 22, 2021

    Recall

    Recall Number
    Z-0496-2022
    Event Number
    89193
    Firm
    Gentherm Medical, LLC
    FEI Number
    1516825
    Product Code
    ILO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 22, 2021
    Terminated
    May 8, 2023
    Address
    12011 Mosteller Rd, Fl 3, Blue Ash, OH, 45241-1528

    Description

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

    Reason

    This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.

    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

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.

    Quantity

    484 devices