Reported Dec 27, 2023 · Ongoing
AirFit N20 Nasal Mask 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 N20 Nasal Mask and User Guide
- Lot codes and dates
- All mask lots used with User Guide 638218/version 2020-02, 638243/version 2020-06, and prior
- UDI-DI/GTIN
619498635016619498635054619498635061619498635351619498635047619498635030619498635078619498635382619498635023619498635344619498635009619498635399619498635115619498635122619498635375619498635214619498635221619498635252619498635245619498635313619498635337619498635207619498635320619498635238619498635092619498635108619498635306619498635290619498635184619498635146619498635160619498635139619498635177619498635153
- Amount recalled
- 7,724,968
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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