medical Class II Updated 2025-01-29

Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 12mm - Silicone; Produc

Recalled Product

Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;


Hazard / Issue

Lack of 510(k) clearance.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: NZ3312; UDI-DI: 09421901970383; Lots: 2008-1461, 2011-2537, 2012-2689, 2012-2842, 2015-3945, 2015-4400, 2016-4554, 2016-4662, 2016-5199, 2016-5283, 2017-6007, 2019-6984, 2020-9242, 2020-9690, 2021-10187, 2021-9918, 2023-10966,
View official government recall

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