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

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: 5,120 units (2190 US, 2930 OUS) 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,

UPC codes

09421901970383

Source

Official record: FDA (Device enforcement) ↗

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