Medline issued the recall due to risk of the inflation tube or other components becoming detached or torn from the main tube. 

RT’s Three Key Takeaways: 

• Medline Industries issued a recall of six SubG endotracheal tubes with subglottic suction and kits containing the devices.
• The inflation tube or other components may become detached and/or torn from the main tube, which could result in increased risk of patient re-intubation, delay in treatment, respiratory distress, and more. 
• The products were manufactured from March 1, 2021, to Jan 1, 2024, and distributed from March 1, 2021, to Feb 20, 2024. 

Medline Industries is recalling six SubG endotracheal tubes with subglottic suction and 10 kits that contain these devices, according to an announcement from the company. 

The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability to inflate. It has also been reported that the main tube is susceptible to tearing. 

The primary health and safety risks due to these defects include increased risk of patient re-intubation, delay in case and/or treatment, respiratory distress from loss of ventilation, uncontrolled loss of airway gases, and, if the device comes apart during use, partial or total airway obstruction and choking. 

These may lead to inefficient ventilation or failure to ventilate and oxygenate, hypoxemia, carbon dioxide retention, acidemia, organ ischemia, cardiorespiratory arrest, regurgitation and aspiration of gastric contents, ventilator associated pneumonia, bradycardia, cardiac arrest, bleeding, tissue damage, and organ damage.

Consumers who have SubG endotracheal tube with subglottic suction should stop using and discard the device. 

Reports of Complaints

Medline Industries voluntarily recalled the product after investigating complaints filed regarding this issue and notified the US Food and Drug Administration of this action.

According to the company, Medline Industries is not aware of any serious health consequences that have occurred due to the device’s use at this time.

Recalled SubG endotracheal tubes with subglottic suction were manufactured from March 1, 2021, to Jan 1, 2024, and distributed from March 1, 2021, to Feb 20, 2024.

Recalled Products

The following kit/tray SKUs are included in the scope of the recall:

Additionally, the following finished good SKUs are included in the scope of the recall:

Products can be identified by their product labeling, which will indicate the name of the device and product number. 

Medline Industries distributed product within the United States, El Salvador, and United Arab Emirates. Medline Industries is notifying its distributors and customers by email and/or first-class mail and is arranging for credit of all recalled product(s).