AirFit N10 Nasal Masks and User Guide
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- ResMed Ltd.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
AirFit N10 Nasal Masks and User Guide
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0536-2024
Related Recalls
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
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
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