April 19, 2024
Signal on the Meals and Drug Administrations campus in Silver Spring, MD. Courtesy FDA

The Meals and Drug Administration on Thursday categorized the recall of sure respiratory masks made by ResMed as “most severe” as their use may trigger main accidents or demise.

San Diego-based ResMed was recalling some fashions of its steady optimistic airway strain (CPAP) masks, AirFit and AirTouch, resulting from doable magnetic interference with sure medical gadgets and implants which could disrupt their operate or place and trigger severe hurt or demise, the FDA stated.

The masks are meant to be used by sufferers who’ve been prescribed non-invasive optimistic airway strain remedy, which makes use of a machine to pump air underneath strain into the airway of the lungs to deal with sleep apnea, in line with the well being regulator.

The FDA stated ResMed was recalling these masks to replace the labels and add extra warnings and knowledge.

The medical machine maker began the recall course of on Nov. 20 and has recalled over 20 million gadgets in the USA.

The well being regulator stated there have been six reported accidents and no studies of demise because of the gadgets.

The gadgets have been distributed between January 2020 and Nov. 20, 2023.