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

Hazard

Lack of 510(k) clearance.

Details from the source

Reason for recall: Lack of 510(k) clearance. Distribution: 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. Quantity: 4,080 units (1510 US, 2570 OUS) Lot/code info: 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.

UPC codes

09421901970413

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.