Device product
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Z-0968-2025
Product summary
- Event
- Event 95942
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 310 units (160 US, 150 OUS)
- Official record key
device-enforcement:Z-0968-2025
Official wording
Reason: Lack of 510(k) clearance.
Code information: Product Code: NZ3312-2; UDI-DI: 09421901970390; Lots: 2014-3634, 2016-4779, 2016-4835, 2016-5062, 2020-9564.
Distribution pattern: US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.
Derived failure modes
-
Unknown
Lack of 510(k) clearance.