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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62514

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 26, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Tango3 LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2138-2012
Recall number
Z-2138-2012
Initiated
March 26, 2012
Classification
Class II
Status
Terminated
Recalling firm
Tango3 LLC
Quantity
44 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

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.

Code information

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.

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.