Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
Adept Medical Ltd is recalling 2,610 T-Tube 9mm otological ventilation tubes distributed without required FDA premarket 510(k) clearance. The affected silicone tubes were sold in the US and internationally.
- Product
- Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
- Category
- Medical Device
- Distribution
- Distributed nationwide