Tango3, LLC
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Tango3, LLC makes
Tango3, LLC manufactures water storage tanks equipped with ozone disinfection systems.
The company's products are Class II medical devices listed in the FDA 510(k) registry, and Tango3, LLC is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Tango3, LLC, initiated on 2012-03-26. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 26 Mar 2012 Z-2138-2012 Class II Terminated 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.
Full distribution text
- 26 Mar 2012 Z-2138-2012 Class II Terminated 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.
Frequently asked questions
How many devices does Tango3, LLC have in the registry?
The registry currently lists 2 devices for Tango3, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tango3, LLC's devices?
Among its 2 most recently registered devices, Tango3, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Tango3, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Tango3, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Tango3, LLC?
FDA recall records list 1 recall initiated by Tango3, LLC, the most recent initiated on 26 Mar 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Tango3, LLC in the registry?
The most recently registered devices listed for Tango3, LLC include TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM.