ResMed Ltd.: AirFit N20 Nasal Mask and User Guide

Hazard

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

Details from the source

Reason for recall: 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 Distribution: US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, Quantity: 7,724,968 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

UPC codes

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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.