FDA Device recall Z-2138-2012
TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067
- FDA Device
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067 by Tango3, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2138-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-26 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tango3 |
| Distribution | CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, NH, NJ, NM, OH, PA, RI, TX, VA |
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
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.
Identifiers
| code_info | Model WOZ -250-PE, Serial #s: 1031, 1032, 1033, 1035, 1036, 1038, 1039, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049,…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, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076 & 1077. Model WOZ-180-SS, Serial #s: 1034, 1037, 1040 & 1064. Model WOZ-240-SS, Serial #s: 1041 & 1052. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2138-2012%22
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