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AIRFIT F30I recallZ-0542-2024 · ResMed Ltd. · initiated Nov 20, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ResMed Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

On 11/20/23, "Urgent Field Safety Notices" and FAQs were placed on the firms website at www.resmed.com/magnetupdate, and these notices were emailed to healthcare providers, and distributors who were asked to do the following: 1) Provide a copy of this notice and the physician letter to prescribing physicians, and/or any other relevant healthcare professionals, notifying them of the updated labeling (contraindications and warning). 2) Provide a copy of the patient letter to all patients currently using an affected mask with magnets, notifying them of the updated labeling (contraindications and warning). Note, patients are instructed in the patient letter to contact their mask provider for a replacement mask if they are now contraindicated. 3) Provide a replacement mask for contraindicated patients to an alternative mask without magnets in a timely manner. Where an alternative mask is not available, inform patients to consult with their physician. 4) Instruct patients to consult their physician and/or manufacturer of their implant / other medical device if they require additional information on the potential adverse effects of magnetic fields for their particular device (as described in warnings). 5) For alternative mask options, please contact your ResMed or Customer Service representative. 6) Complete and return the customer acknowledgement form via email to [email protected] For any questions, please contact your local ResMed contact or visit www.resmed.com/contact.

Recall details

Recall number
Z-0542-2024
Status
Open, Classified
Initiated by the company
Nov 20, 2023
Posted by the FDA
Dec 21, 2023
Recalling firm
ResMed Ltd.
Quantity
2,037,323
Product code
BZD
FDA submissions
K183512
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, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA

Product description

AirFit F30i Full Face Mask and User Guide

Code information (models, lots, serial numbers)

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

Devices named in this recall

9 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93499).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page