ResMed Ltd.: AirFit F30i Full Face 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: 2,037,323 Lot/code info: All mask lots used with User Guide 638225/version 2020-02, and prior. UDI-DI/GTIN: 619498633326, 619498633067, 619498633012, 619498633340, 619498633302, 619498633333, 619498633050, 619498633319, 619498633005, 619498633135, 619498633128, 619498633364, 619498633388, 619498633371, 619498633401, 619498633395, 619498633104, 619498633142, 619498633111, 619498633081, 619498633074

UPC codes

619498633326, 619498633067, 619498633012, 619498633340, 619498633302, 619498633333, 619498633050, 619498633319, 619498633005, 619498633135, 619498633128, 619498633364, 619498633388, 619498633371, 619498633401, 619498633395, 619498633104, 619498633142, 619498633111, 619498633081, 619498633074

Source

Official record: FDA (Device enforcement) ↗

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