The FDA identified a recall of Medline Sub-G endotracheal tubes with subglottic suctioning as Class I, the most serious kind.
This recall, initiated in February, includes removing devices from where they are used or sold. It includes six Sub-G endotracheal tubes with subglottic suction and 10 kits that contain these devices. Customers in possession of the kits should immediately check their stock and destroy any affected inventory.
The Sub-G endotracheal tube helps patients breathe by inserting it through the mouth and into the windpipe. It also helps to drain fluids from the upper part of the windpipe. Its design aims to keep the airway open so the patient can receive oxygen, medicine or anesthesia. Uses include people with conditions like pneumonia, emphysema, heart failure, a collapsed lung, or severe injuries. It also helps clear blockages from the airway.
Medline recalled the tubes due to potential detachment or tearing of the inflation tube and other device components from the main tube. This can result 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.
According to the FDA notice, Medline also received reports of susceptibility of the main tube to tearing. Users also reported difficulty connecting, with potential detaching during use, of the suction port.
Using the tube may lead to adverse health consequences. That includes 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 reports three injuries and no deaths related to the recalled devices.
