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.
FDA Recall Z-2138-2012 · Posted 2012-08-03
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Recalling FirmTango3 LLC
Recall StatusTerminated
Product CodeFIN
Date Initiated2012-03-26
Date Terminated2013-03-01
Product Quantity44 units
Reason for Recall
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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