medical Class I Updated 2023-12-27

ResMed Ltd. recalls AirTouch N20 Nasal Mask and User Guide

Recalled Product

AirTouch 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, and prior. UDI-DI/GTIN: 619498639069, 619498639045, 619498639052, 619498639021, 619498639038, 619498639007, 619498639076, 619498639014, 619498639540, 619498639205, 619498639229, 619498639113, 619498639090, 619498639120, 619498639212
View official government recall

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