FDA-Device2025-01-29Class II
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Adept Medical Ltd
Hazard
Lack of 510(k) clearance.
Sold states
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.
Affected count
4,080 units (1510 US, 2570 OUS)
Manufactured in
2-6 Mc Donald Street, Morningside, Po Box 10075 Dominion Rd, Auckland, New Zealand
Products
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0970-2025Don't want to check this manually?
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