Device product
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Z-0964-2025
Product summary
- Event
- Event 95942
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,010 units (630 US, 1380 OUS)
- Official record key
device-enforcement:Z-0964-2025
Official wording
Reason: Lack of 510(k) clearance.
Code information: Product Code: NZ3306-2; UDI-DI: 09421901970352; Lots: 2009-1820, 2013-3195, 2014-3504, 2015-4220, 2016-4652, 2016-5211, 2019-6966, 2022-10349,
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.