Reported Jan 29, 2025 · Ongoing
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
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 9mm - Silicone
- Product CodeNZ3309
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published NZ3309— — 09421901970369UDI-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 - Amount recalled
- 6,280 units (2500 US, 3780 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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