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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.
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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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 ...
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.
On February 2, 2023, the CDC advised people to stop using EzriCare Artificial Tears and said that the eye drops were contaminated. The P. aeruginosa strain had been found in 55 people across 12 states as of January 31, resulting in one death and vision loss in five people. A recall was ordered for EzriCare Artificial Tears, which later included ...