Reported Dec 27, 2023 · Ongoing
AirTouch 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?
- AirTouch N20 Nasal Mask and User Guide
- Lot codes and dates
- All mask lots used with User Guide 638218/version 2020-02, and prior
- UDI-DI/GTIN
619498639069619498639045619498639052619498639021619498639038619498639007619498639076619498639014619498639540619498639205619498639229619498639113619498639090619498639120619498639212
- Amount recalled
- 424,309
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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