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(Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of certain respiratory masks made by ResMed as most serious as their use could cause major injuries or death.
The FDA defines a recall as a method of removing or correcting products that are in violation of laws administered by the health regulator and does not include a market withdrawal. ResMed's masks ...
The company said patients' health is its top priority, and regretted the "distress and concern" that the recall caused. It said complaints about the foam were limited and were evaluated on a case-by-case basis, and it was made aware of the significance in early 2021, launching the recall soon after.
ResMed Inc. is an American medical equipment company based in San Diego, California.It primarily provides cloud-connectable medical devices for the treatment of sleep apnea (such as CPAP devices and masks), chronic obstructive pulmonary disease (COPD), and other respiratory conditions.
A full face mask over the mouth and nose is another approach for people who breathe out of their mouths when they sleep. [13] Often, oral masks and naso-oral masks are used when nasal congestion or obstruction is an issue. [medical citation needed] There are also devices that combine nasal pressure with mandibular advancement devices (MAD).
The emergence of two prominent COVID variants—BA.2.86 and EG.5—have left many wondering whether mask mandates will be reinstated by the CDC. See what to know.
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Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs).
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