Recall Z-2138-2012 ยท FIN Tank, Holding, Dialysis
Tango3 LLC
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.
| Date | Aug 3, 2012 (initiated Mar 26, 2012) |
| Status | Terminated |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093641 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM Tango3, LLC, Dec 8, 2010 |