Reported Jan 29, 2025 · Ongoing
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Adept Medical Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Adept Medical Ltd · 2-6 Mc Donald Street · Auckland · N/A
Is this the product you have?
- Otological Ventilation Tube - T-Tube 12mm - Silicone
- Product CodeNZ3312
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published NZ3312— — 09421901970383UDI-DI: 09421901970383 — Lots: 2008-1461, 2011-2537, 2012-2689, 2012-2842, 2015-3945, 2015-4400, 2016-4554, 2016-4662, 2016-5199, 2016-5283, 2017-6007, 2019-6984, 2020-9242, 2020-9690, 2021-10187, 2021-9918, 2023-10966 - Amount recalled
- 5,120 units (2190 US, 2930 OUS)
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of 510(k) clearance.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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