FDAFDA · Food and drugs·Recall number Z-0969-2025
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
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: NZ3321; UDI-DI: 09421901970406; Lots: 2017-5547, 2018-6609, 2023-10988, 2015-4105, 2016-4595, 2016-4760, 2016-5201, 2017-5536, 2017-5547, 2018-6609, 2019-7331, 2023-10988, 2023-11130.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- New Zealand
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