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U.S. Department of Health and Human Services

Class 1 Device Recall AirFit N10

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  Class 1 Device Recall AirFit N10 see related information
Date Initiated by Firm November 20, 2023
Date Posted December 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-0536-2024
Recall Event ID 93499
510(K)Number K132887  
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
Product AirFit N10 Nasal Masks and User Guide
Code Information All mask lots used with User Guide 628153/version 2020-07, and prior. UDI-DI/GTIN: 619498632008, 619498632893, 619498632060, 619498632077, 619498632299, 619498632015, 619498632084, 619498632022, 619498632237, 619498632190, 619498632213, 619498632220, 619498632183, 619498632206, 619498632268, 619498632244, 619498632114, 619498632251, 619498632091, 619498632107, 619498632152, 619498632121, 619498632138, 619498632275, 619498632169, 619498632145, 619498632176
Recalling Firm/
Manufacturer		 ResMed Ltd.
1 Elizabeth Macarthur Dr
Bella Vista Australia
Manufacturer 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
FDA Determined
Cause 2		 Device Design
Action 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 magnetresponse@resmed.com For any questions, please contact your local ResMed contact or visit www.resmed.com/contact.
Quantity in Commerce 199,796
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BZD and Original Applicant = RESMED LTD.
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