ResMed masks to remain on market despite recall: report

Hope Connolly/iStock via Getty Images ResMed ( NYSE: RMD ) intends to keep its CPAP masks that utilize magnets on the market despite a recall because it regards the action as a labeling correction rather than a product removal. According to Reuters , ResMed said that the masks, which use magnets to help secure a proper fit, will remain in use even though the FDA has classified the recall as a Class I, its most type of recall.

ResMed has warned that the masks should not be used around certain medical devices or implants, such as pacemakers or aneurysm clips, because of the risk of magnetic interference. The masks are used for CPAP or bi level therapy to treat conditions such as sleep apnea. The FDA issued a Class I recall last week for certain ResMed AirFit and AirTouch masks over concerns that magnets contained the masks could interfere with certain medical devices and implants.

It added that Resmed was in the process of updating the product’s labels, adding more warnings and information for safe usage. The agency also noted that it had received six reports of injury related to the products, but no reports of death. Class I recalls are issued if the FDA believes the product could cause serious injury or death.

The agency’s website noted, however, that the recall was considered a product correction rather than a product removal. Resmed issued a safety notice for the masks in November, warning users and healthcare professionals that the magnets could interfere with certain devices and implants. The company updated its product guides for the masks advising users of potential magnet interference issues in December.

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