Reported Jan 29, 2025 · Ongoing
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
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 - Double - Silicone
- Product CodeNZ3309-2
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published NZ3309-2— — 09421901970376UDI-DI: 09421901970376 — Lots: 2009-1822, 2012-2723, 2013-3079, 2014-3452, 2014-3506, 2015-4277, 2016-4527, 2016-4664, 2016-4997, 2016-4997, 2017-5441, 2017-5674, 2017-6117, 2018-6458, 2018-6896, 2020-9591. - Amount recalled
- 2,610 units (240 US, 2370 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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