medical Class II Updated 2025-01-29

Adept Medical Ltd recalls Otological Ventilation Tube - Donaldson - Double - Blue Sili

Recalled Product

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


Hazard / Issue

Lack of 510(k) clearance.

Issued by

FDA

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

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