medical Class II Updated 2025-01-29

Adept Medical Ltd recalls Otological Ventilation Tube - Donaldson - Blue Silicone; Pro

Recalled Product

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


Hazard / Issue

Lack of 510(k) clearance.

Issued by

FDA

Distribution: Nationwide (United States)
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.
View official government recall

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