ResMed Ltd.: AirTouch F20 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: 3,816,138 Lot/code info: All mask lots used with User Guide 638220/version 2020-02, and prior. UDI-DI/GTIN: 619498630028, 619498630189, 619498630172, 619498630141, 619498630059, 619498630097, 619498630080, 619498630011, 619498630004, 619498630042, 619498630066, 619498630134, 619498630073, 619498630035, 619498630158, 619498630165, 619498630523, 619498630530, 619498630516, 619498630363, 619498630356, 619498630349, 619498630387, 619498630370

UPC codes

619498630028, 619498630189, 619498630172, 619498630141, 619498630059, 619498630097, 619498630080, 619498630011, 619498630004, 619498630042, 619498630066, 619498630134, 619498630073, 619498630035, 619498630158, 619498630165, 619498630523, 619498630530, 619498630516, 619498630363, 619498630356, 619498630349, 619498630387, 619498630370

Source

Official record: FDA (Device enforcement) ↗

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