TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3… — recall Z-2138-2012
U.S. FDA — Device Enforcement · United States · 2012-03-26 · Class II
As described by U.S. FDA — Device Enforcement: 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
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
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.
Reported risk: 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.
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