Otological Ventilation Tubes Recalled for Lack of FDA 510(k) Clearance
Adept Medical Ltd is recalling 2,440 otological ventilation tubes due to lack of FDA 510(k) regulatory clearance. The recall affects 1,940 units in the US and 500 units distributed internationally.
- Product
- Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
- Category
- Medical Device
- Distribution
- Distributed nationwide