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Medline Industries recalls Sub-G endotracheal tube

Medline Industries, LP is recalling the Sub-G Endotracheal Tube with Subglottic Suction due to detachment or tearing of the inflation tube and other device components from the main tube, resulting in cuff leakage, deflation, moisture buildup, and failure to inflate. Additionally, if the device comes apart during use, partial or total airway obstruction and choking may occur. There have also been reports that the main tube is susceptible to tearing and the suction port is hard to connect or can detach during use.

The use of affected Sub-G Endotracheal Tube with Subglottic Suction may cause serious adverse health consequences, including low oxygen (hypoxemia), unplanned removal of a breathing tube (forced extubation), need for putting in a new breathing tube (re-intubations), ventilator associated pneumonia from regurgitation and aspiration of gastric contents, respiratory distress and carbon dioxide accumulation (acidosis) from inefficient ventilation or failure to ventilate, cardiac arrest, no oxygen to the brain (brain anoxia), tissue and organ damage, and death.

The FDA has received three reports of injuries for the recalled devices. There have been no reports of death for the recalled devices.

Device use
The Sub-G Endotracheal Tube is used to help patients breathe by inserting it through the mouth and into the windpipe. It also helps drain fluids from the upper part of the windpipe. This tube is used to keep the airway open so that oxygen, medicine, or anesthesia can be given. It is often used for patients with conditions like pneumonia, emphysema, heart failure, a collapsed lung, or severe injuries. It also helps clear blockages from the airway. U.S. Food and Drug Administration

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