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Published: 2012-08-15Captured: 2026-02-09Tango3 LLCProduct: 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 ...

FDA issued a Class II enforcement action. Affects Tango3 LLC. Reason: During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for de.

  • Classification: Class II
  • Firm: Tango3 LLC
  • Status: Terminated
  • Distribution: Product was shipped to the following states: CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME...
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 re...

Status:Terminated
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.

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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. | TrueMedDevice