Reported Dec 27, 2023 · Ongoing
AirFit N10 Nasal Masks and User Guide
ResMed Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: ResMed Ltd. · 1 Elizabeth Macarthur Dr · Bella Vista, N/A · N/A
Is this the product you have?
- AirFit N10 Nasal Masks and User Guide
- Lot codes and dates
- All mask lots used with User Guide 628153/version 2020-07, and prior
- UDI-DI/GTIN
619498632008619498632893619498632060619498632077619498632299619498632015619498632084619498632022619498632237619498632190619498632213619498632220619498632183619498632206619498632268619498632244619498632114619498632251619498632091619498632107619498632152619498632121619498632138619498632275619498632169619498632145619498632176
- Amount recalled
- 199,796
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Stop using this product now
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
Using this product could cause serious injury, illness or death — stop using it now.
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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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