Medline told customers of 89 lots of endotracheal tubes to destroy inventory after receiving reports of the inflation tube tearing and detaching, the FDA said June 11.
The medical devicemaker's Sub-G Endotracheal Tube is used to keep an airway open, drain fluids, clear blockages and help patients breathe, according to the FDA. Six Sub-G Endotracheal Tubes with Subglottic Suction products and 10 kits that contain the devices were recalled in February.
Customers have reported issues with the product's main tube, which can lead to 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," the FDA said. "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 problems can cause hypoxemia, forced extubation, re-intubations, ventilator-associated pneumonia, respiratory distress, cardiac arrest, brain anoxia, tissue and organ damage, and death, the FDA said. Three injuries and zero deaths have been reported.