AirTouch N20 Nasal Mask and User Guide

Class I - Dangerous
🏥 Medical Devices Recalled: November 20, 2023 ResMed Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All mask lots used with User Guide 638218/version 2020-02, and prior. UDI-DI/GTIN: 619498639069, 619498639045, 619498639052, 619498639021, 619498639038, 619498639007, 619498639076, 619498639014, 619498639540, 619498639205, 619498639229, 619498639113, 619498639090, 619498639120, 619498639212
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:

AirTouch N20 Nasal Mask and User Guide

Product Codes/Lot Numbers:

All mask lots used with User Guide 638218/version 2020-02, and prior. UDI-DI/GTIN: 619498639069, 619498639045, 619498639052, 619498639021, 619498639038, 619498639007, 619498639076, 619498639014, 619498639540, 619498639205, 619498639229, 619498639113, 619498639090, 619498639120, 619498639212

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0540-2024

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

Nov 20, 2023 Other Medical Devices Nationwide View Details →

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

Nov 20, 2023 Other Medical Devices Nationwide View Details →
Class I - Dangerous

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

Nov 20, 2023 Other Medical Devices Nationwide View Details →