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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's masks are safe to be used when kept at a distance of at least 6 inches away from implants or medical devices that may be adversely affected by magnetic interference, according to the ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
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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.
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.
A federal agency on Friday recalled toys sold at Walmart.com containing powerful magnetic balls that could pose a hazard to children if swallowed. The Consumer Product Safety Commission said the ...
Jonah is a skinny, gormless, chinless wonder of a sailor, feared by other mariners because of his clumsiness. He has (accidentally) sunk every ship he has sailed on (as well as all other vessels surrounding, at times), and started a war between the nations of Gorgonzolia and Parafinalia, resulting in the utter destruction of the combined fleets of both countries (a possible reference to the ...