FDAFDA · Food and drugs·Recall number Z-0966-2025
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Published January 29, 2025 · Recall initiated: November 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of 510(k) clearance.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Adept Medical Ltd
- Distributor
- 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.
- Lot
- Product Code: NZ3309; UDI-DI: 09421901970369; Lots: 2008-1459; 2009-1864; 2011-2331, 2012-2961, 2013-3122, 2013-3363, 2014-3783, 2014-3832, 2015-3943, 2016-4601, 2016-5197, 2017-5651, 2017-6150, 2018-6487, 2018-6818, 2019-7211, 2021-10033, 2022-10783, 2023-11053,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- New Zealand
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