BEUDAMED
    FDA Recall Terminated

    TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility.

    Recall: Z-2138-2012 · Initiated March 26, 2012

    Recall

    Recall Number
    Z-2138-2012
    Event Number
    62514
    FEI Number
    3008775673
    Product Code
    FIN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 26, 2012
    Posted
    August 3, 2012
    Terminated
    March 1, 2013
    Address
    Tango3 LLC 132 Citizens Blvd, Simpsonville, KY, 40067-6547

    Description

    TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility.

    Reason

    During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized modifications that were either not reviewed or received proper clearance from FDA. There was no assurance that all systems in the field were working properly and operating at a minimum of 0.2ppm of ozone.

    Action

    On 3/26/2012, the firm sent "Urgent: Customer Notification" letters and Acknowledgement Forms to their customers. The issue was described and recommended actions were provided. Customers were given the number 866-782-7286 to call if questions.

    Distribution

    Product was shipped to the following states: CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, NH, NJ, NM, OH, PA, RI, TX and VA.

    Quantity

    44 units