TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Model
FDA device recall Z-2138-2012 · posted 2012-08-03 · Terminated
Recall details
- Recalling firm
- Tango3 LLC
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FIN
- Quantity affected
- 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.
- Date initiated
- 2012-03-26
- Date posted
- 2012-08-03
- Date terminated
- 2013-03-01
- Location
- Simpsonville, KY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (K093641) | Tango3, LLC | 2010-12-08 |