Adept Medical Ltd: Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

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: 2,610 units (240 US, 2370 OUS) Lot/code info: Product Code: NZ3309-2; UDI-DI: 09421901970376; Lots: 2009-1822, 2012-2723, 2013-3079, 2014-3452, 2014-3506, 2015-4277, 2016-4527, 2016-4664, 2016-4997, 2016-4997, 2017-5441, 2017-5674, 2017-6117, 2018-6458, 2018-6896, 2020-9591.

UPC codes

09421901970376

Source

Official record: FDA (Device enforcement) ↗

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