Adept Medical Ltd: Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;

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: 2,010 units (630 US, 1380 OUS) Lot/code info: Product Code: NZ3306-2; UDI-DI: 09421901970352; Lots: 2009-1820, 2013-3195, 2014-3504, 2015-4220, 2016-4652, 2016-5211, 2019-6966, 2022-10349,

UPC codes

09421901970352

Source

Official record: FDA (Device enforcement) ↗

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