Device product

Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;

Z-0969-2025

November 24, 2024

Class II

Product summary

Firm: Adept Medical Ltd
Event: Event 95942
Status: Ongoing
Classification: Class II
Quantity: 2,440 units (1940 US, 500 OUS)
Official record key: device-enforcement:Z-0969-2025

Official wording

Reason: Lack of 510(k) clearance.

Code information: Product Code: NZ3321; UDI-DI: 09421901970406; Lots: 2017-5547, 2018-6609, 2023-10988, 2015-4105, 2016-4595, 2016-4760, 2016-5201, 2017-5536, 2017-5547, 2018-6609, 2019-7331, 2023-10988, 2023-11130.

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
reason.no_named_rule · v1.0.0

Lack of 510(k) clearance.