Tango3 Water Storage Tank Recalled for Quality System Deficiencies
Tango3 LLC is recalling 44 water storage tanks with ozone disinfection systems due to quality system deficiencies and lack of assurance that systems operate at minimum ozone levels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of assurance that the ozone disinfection system operates at the required minimum level, which poses a risk of harm to patients in dialysis facilities, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Tango3 LLC is recalling 44 units of the TANGO3 Water Storage Tank with Ozone Disinfection System. The affected models are WOZ-250-PE, WOZ-240-SS, and WOZ-180-SS. These devices are intended for the disinfection of water distribution systems in dialysis facilities.
The recall was initiated after an FDA inspection identified Quality System deficiencies. Specifically, the firm lacked procedures for design control and customized modifications that were not reviewed or received proper clearance from the FDA. Consequently, there was no assurance that all systems in the field were working properly and operating at a minimum of 0.2ppm of ozone.
The product was shipped to dialysis facilities in 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. Affected serial numbers for the WOZ-250-PE model range from 1031 to 1077 (excluding 1034, 1037, 1040, 1041, 1052, and 1064). The WOZ-180-SS model includes serial numbers 1034, 1037, 1040, and 1064. The WOZ-240-SS model includes serial numbers 1041 and 1052.
The recalled product
- 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 dis
- Manufacturer
- Tango3 LLC
- Category
- Medical Device — Water Treatment
- Affected units
- 44
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model WOZ -250-PE
- Serial #s: 1031
- 1032
- 1033
- 1035
- 1036
- 1038
- 1039
- 1042
- 1043
- 1044
- 1045
- 1046
- 1047
- 1048
- 1049
- 1050
- 1051
- 1053
- 1054
Distribution
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