Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.
- Product
- Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
- Category
- Medical Device
- Distribution
- Distributed nationwide