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Adept Medical Ltd recalls Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Recalled January 29, 2025 · FDA recall Z-0964-2025 · Adept Medical
Hazard
Lack of 510(k) clearance. · FDA Class II
Units
2,010 units (630 US, 1380 OUS)
Sold at
US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.
Description
Lack of 510(k) clearance.
Product
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Manufacturer(s)
Adept Medical Ltd
Made in
New Zealand
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →