BEUDAMED
    FDA Recall Open, Classified

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

    Recall: Z-1360-2022 · Initiated April 28, 2022

    Recall

    Recall Number
    Z-1360-2022
    Event Number
    90389
    Firm
    Isopure Corp
    FEI Number
    3013942511
    Product Code
    FIN
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    April 28, 2022
    Address
    11851 Plantside Dr, Louisville, KY, 40299-6328

    Description

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

    Reason

    Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent such events from occurring.

    Action

    Firm began to call customers on April 28, 2022, to determine if the IsoMix Pro is still in use at each location. The firm will also be sending an email out to all clinics along with an updated Safety Notice. Once information is gathered, service technicians will visit each clinic to assess the devices. Customers will be provided with a video link as part of an inspection packet on proper use of a torque screwdriver. Customers should follow the provided guidance documents. Customers should always replace any depleted or blown fuses with the correct size. Customers are also instructed to follow the recommended preventive maintennace schedule for the device.

    Distribution

    Domestic distribution to AL AZ CO DE FL GA IN KS KY LA MA MD ME MN MO NC NY OK PA TX UT VA WV No foreign distribution.

    Quantity

    119