Otological Ventilation Tubes recalled due to lack of FDA 510(k) clearance
Adept Medical Ltd is recalling 310 units of Otological Ventilation Tubes (Product Code NZ3312-2) distributed in the US and internationally due to lack of FDA 510(k) regulatory clearance. The devices were distributed without required FDA pre-market approval.
- Product
- Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
- Category
- Medical Device
- Distribution
- Distributed nationwide