Device product

Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

Z-0970-2025

November 24, 2024

Class II

Product summary

Firm: Adept Medical Ltd
Event: Event 95942
Status: Ongoing
Classification: Class II
Quantity: 4,080 units (1510 US, 2570 OUS)
Official record key: device-enforcement:Z-0970-2025

Official wording

Reason: Lack of 510(k) clearance.

Code information: Product Code: NZ3321-2; UDI-DI: 09421901970413; Lots: 2015-4222, 2016-4893, 2016-5236, 2016-5408, 2017-5538, 2017-5790, 2017-6047, 2017-6233, 2018-6361, 2018-6735, 2019-6970, 2022-10451, 2023-11068.

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.