Medline Industries, LP Recalls Sub-G Endotracheal Tube with Subglottic Suction Due to Serious Health Risks

According to a June 11 announcement, 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.

This recall involves removing devices from where they are used or sold.

The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.