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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 ...
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 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.
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Bag valve mask. Part 1 is the flexible mask to seal over the patients face, part 2 has a filter and valve to prevent backflow into the bag (prevents patient deprivation and bag contamination) and part 3 is the soft bag element which is squeezed to expel air to the patient
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.
The recall group will need to collect about 5,000 signatures per board member to put their names to the recall ballot. Recall petitions that make it to the ballot need 50% of the vote, plus 1, to ...