Medline Has Class I Recall of Sub-G Endotracheal Tubes

Medline’s recall of its Sub-G endotracheal tube with subglottic suctioning has been deemed Class I by the U.S. Food and Drug Administration (FDA), the most serious type of recall.
 
The endotracheal tube was recalled because of reports of detachment or tearing of the inflation tube and other components from the main tube. This causes cuff leakage, deflation, moisture buildup, and failure to inflate. Further, if the device comes apart mid-use, partial or total airway obstruction and choking can 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.
 
Using the affected endotracheal tubes can cause hypoxemia, forced extubation, re-intubations, ventilator associated pneumonia from regurgitation and aspiration of gastric contents, acidosis from inefficient ventilation or failure to ventilate, cardiac arrest, brain anoxia, tissue and organ damage, and death.
 
So far, the FDA has received three reports of injury from the recalled devices, with no reports of death.
 
This recall involves removing devices from where they’re used or sold. Customers were urged to immediately check stock for the affected item number and lot numbers, then destroy any affected inventory.
 
Medline said it will issue credit for the product, based on quantity and lot numbers identified on a submitted response form.

More about the Sub-G Endotracheal Tube

The device 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 administered. It’s often used for patients with pneumonia, emphysema, heart failure, a collapsed lung, or severe injuries. It also helps clear blockages from the airway.