Otological Ventilation Tubes Distributed Without FDA 510(k) Clearance
Adept Medical Ltd is recalling 2,010 units of T-Tube 6mm Double Silicone otological ventilation tubes distributed without required FDA 510(k) clearance. The recall affects 630 US units and 1,380 international units.
- Product
- Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
- Category
- Medical Device
- Distribution
- Distributed nationwide