Medline has a major endotracheal tube recall

The FDA has classified the recall of Medline Sub-G endotracheal tubes with subglottic suction as a Class I recall, the most serious type.

The recall, which began in February, includes the removal of the devices from places where they are used or sold. Includes six Sub-G endotracheal tubes with subglottic suction and 10 sets containing these devices. Customers in possession of kits should immediately check stock levels and destroy any affected stock.

The Sub-G endotracheal tube helps patients breathe by inserting it through the mouth into the windpipe. It also helps drain fluids from the top of the trachea. Its design is intended to keep the airway open so that the patient can receive oxygen, medicine or anesthesia. Applications include people suffering from conditions such as pneumonia, emphysema, heart failure, collapsed lung, or serious injury. It also helps in removing blockages in the respiratory tract.

Medline recalled the tube due to the filling tube and other device components disconnecting or breaking from the main tube. This can cause the cuff to leak, deflate, accumulate moisture, and fail to inflate. Additionally, if the device breaks down during use, partial or complete airway obstruction and choking may occur.

According to the FDA notice, Medline has also received reports of the main tube being susceptible to tearing. Users have also reported difficulty connecting, or even disconnecting, the suction port during use.

Using the tube may result in adverse health consequences. These include low oxygen levels (hypoxemia), unplanned removal of the breathing tube (involuntary extubation), need for a new breathing tube (re-intubation), ventilator-related pneumonia due to regurgitation and aspiration of gastric contents, respiratory failure, and carbon dioxide buildup (acidosis) caused by ineffective or no ventilation, cardiac arrest, lack of oxygen in the brain (cerebral hypoxia), tissue and organ damage and death.

The FDA reports three injuries and no deaths related to the recalled devices.