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The FDA said ResMed was recalling these masks to update the labels and add more warnings and information. The California-based medical device maker started the recall process on Nov. 20 and has ...
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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.
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A product recall is a request from a manufacturer to return a product after the discovery of safety issues or product defects that might endanger the consumer or put the maker or seller at risk of legal action. Product recalls are one of a number of corrective actions that can be taken for products that are deemed to be unsafe.
The simple face mask can deliver higher flow rates than nasal cannula (6–10 liters per minute) for an FiO2 of 30- 60% oxygen. [1] Nasal cannula and simple face masks are described as low flow delivery systems. [2] [3] Unlike the non-rebreather and partial rebreather masks, the simple face mask lacks a reservoir bag.
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related to: resmed airfit mask recall registration portal downloadeasybreathe.com has been visited by 100K+ users in the past month