Adept Medical Ltd: Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

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: 310 units (160 US, 150 OUS) Lot/code info: Product Code: NZ3312-2; UDI-DI: 09421901970390; Lots: 2014-3634, 2016-4779, 2016-4835, 2016-5062, 2020-9564.

UPC codes

09421901970390

Source

Official record: FDA (Device enforcement) ↗

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