Otological Ventilation Tubes Recalled for Missing FDA 510(k) Clearance
Adept Medical Ltd is recalling 13,070 Otological Ventilation Tubes because they were distributed without FDA 510(k) clearance. Over 9,000 units were distributed in the US and 3,980 internationally.
- Product
- Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
- Category
- Medical Device
- Distribution
- Distributed nationwide