Class I Recall of ResMed’s CPAP Masks
Thursday, ResMed Ltd RMD said it is recalling some of its Continuous Positive Airway Pressure (CPAP) masks with magnets due to possible interference with certain medical devices.
Under certain circumstances, when a magnet is nearby (less than 2 inches) to certain medical implants and devices, it might disrupt their function or position, possibly causing serious harm or death.
The FDA has identified this as a Class I recall, the most serious type of recall.
While the existing label advises keeping magnets 2 inches away from affected medical devices, it doesn’t list all the specific ones that could be affected by the masks’ magnets.
ResMed is recalling these masks to update the labels and add more warnings and information to guide patients and healthcare professionals on safe usage when using masks with magnets.
This recall and label update came after a review of potential risks to medical implants due to magnetic interference.
The use of affected masks may cause serious adverse health consequences and death.
There have been six reported injuries. There have been no reports of death.
The medical device maker started the recall process on November 20, 2023, and has recalled over 20 million devices in the U.S.
The AirFit and AirTouch masks are non-continuous ventilatory devices intended to be used by patients weighing more than 66 lbs. who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy.
The masks are meant for reuse by one person at home or by multiple people in hospitals.
The devices have magnets on the lower headgear straps and frame connections of CPAP masks. These magnets are there to make wearing the mask more comfortable.
ResMed sent an advisory letter stating to keep the magnets at a safe distance of six inches (150 mm) away from implants or medical devices that could be affected by magnetic interference.
ResMed started the recall process on November 20, 2023, and has recalled over 20 million devices in the U.S.
ResMed sent an advisory letter stating to keep the magnets at a safe distance of six inches away from implants or medical devices.
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