TANGO3 Water Storage Tank with Ozone Disinfection System — Class II medical device recall Z-2138-2012
Terminated recall by Tango3 LLC, reported 2012-08-15, distributed in CA, CO, CT, DE, FL, GA, IA, ID…. During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedu
| Recall number | Z-2138-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tango3 LLC, Simpsonville, KY, United States |
| Recall initiated | 2012-03-26 |
| Classified | 2012-08-03 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2013-03-01 |
| Distributed | CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, NH, NJ, NM, OH, PA, RI, TX, VA |
| Quantity | 44 units |
| Serial numbers | 1031, 1032, 1033, 1034, 1035, 1036, 1037, 1038, 1039, 1040, 1041, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049, 1050, 1051, 1052, 1053, 1054, 1055 and 22 more |
| Model numbers | 250-PE, TANGO3, WOZ-180-SS, WOZ-240-SS, WOZ-250-PE |
Product
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.