FDA classifies ResMed recall
By HME News Staff
Updated 10:11 AM CST, Mon January 15, 2024
WASHINGTON – The U.S. Food and Drug Administration has classified ResMed’s recall of CPAP masks with magnets a Class I recall, the most serious type.
ResMed in November issued an urgent field safety notice to patients detailing possible interference with its AirFit and AirTouch masks and certain medical devices. Then the company in December announced a voluntary global field action to update its guides.
“ResMed is recalling these masks to update the labels, add more warnings and information to guide patients and health care professionals on safe usage when using masks with magnets,” the FDA states. “This recall and label update came after a review of potential risks to medical implants due to magnetic interference.”
There have been six reported injuries due to the issue, according to the FDA, and no reports of death.
The FDA noted ResMed’s communications to patients to keep magnets at a safe distance of six inches away from certain medical devices; reach out to their physician or the manufacturer of their medical device for further details on possible negative effects of magnetic fields; and visit the ResMed Magnet Update website for updates to contraindications and warning labels.
Comments