Z-2138-2012Class II

TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY...

Name: Z-2138-2012 TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY...
Creator: Tango3 LLC
Published: 2012-03-26
License: https://open.fda.gov/license/

Tango3, LLC / initiated 2012-03-26 / Terminated / root cause: manufacturing process

FDA source

Tango3 LLC began a recall of TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS... on 2012-03-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2138-2012
Classification: Class II
Status: Terminated
Initiated: 2012-03-26
Posted: 2012-08-03
Terminated: 2013-03-01
Recalling firm: Tango3, LLC
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.
Product code: FIN Tank, Holding, Dialysis
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 44 units
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2138-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2138-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-03

Product code FIN

K093641Class IITango3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC / cleared 2010-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)