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

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: 2,440 units (1940 US, 500 OUS) Lot/code info: 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.

UPC codes

09421901970406

Source

Official record: FDA (Device enforcement) ↗

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