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Class 2 Device Recall TANGO3 Water Storage Tank with Ozone Disinfection System |
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Date Initiated by Firm |
March 26, 2012 |
Date Posted |
August 03, 2012 |
Recall Status1 |
Terminated 3 on March 01, 2013 |
Recall Number |
Z-2138-2012 |
Recall Event ID |
62514 |
510(K)Number |
K093641
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Product Classification |
Tank, holding, dialysis - Product Code FIN
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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. |
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. |
Recalling Firm/ Manufacturer |
Tango3 LLC 132 Citizens Blvd Simpsonville KY 40067-6547
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For Additional Information Contact |
Hubert D. Doss 502-722-5615
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Manufacturer 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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FIN and Original Applicant = TANGO3, LLC
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