Reported Dec 27, 2023 · Ongoing
AirFit F20 Full Face 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 F20 Full Face Mask and User Guide
- Lot codes and dates
- All mask lots used with User Guide 638220/version 2020-02, 638238/version 2020-12, 638221/version 2020-01, and prior
- UDI-DI/GTIN
619498634019619498634484619498634460619498634002619498634453619498634033619498634569619498634477619498634026619498634040619498634491619498634507619498634521619498634538619498640065619498640072619498634064619498640096619498634316619498640058619498634118619498640119619498634071619498634248619498634217619498634224619498634330619498634200619498634347619498634323619498634309619498634255619498634231619498634279619498634286619498634262619498634057619498634293619498634095619498634088619498634361619498634378619498634354619498640218619498640201619498640225619498634132619498634187619498634163619498634101619498634156619498634125619498634170619498640089619498640140619498634149619498640102619498640126619498640133619498634194
- Amount recalled
- 11,885,039
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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