medical Class I Updated 2023-12-27

ResMed Ltd. recalls AirFit N20 Nasal Mask and User Guide

Recalled Product

AirFit N20 Nasal Mask and User Guide

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All mask lots used with User Guide 638218/version 2020-02, 638243/version 2020-06, and prior. UDI-DI/GTIN: 619498635016, 619498635054, 619498635061, 619498635351, 619498635047, 619498635030, 619498635078, 619498635382, 619498635023, 619498635344, 619498635009, 619498635399, 619498635115, 619498635122, 619498635375, 619498635214, 619498635221, 619498635252, 619498635245, 619498635313, 619498635337, 619498635207, 619498635320, 619498635238, 619498635092, 619498635108, 619498635306, 619498635290, 619498635184, 619498635146, 619498635160, 619498635139, 619498635177, 619498635153
View official government recall

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