close
close

FDA Designates Medline Recall for Endotracheal Tubes as Class I

Posted on by darion

According to the FDA’s recall database, 168,632 tubes and 13,092 kits are affected. Image source: Shutterstock / Bankrx.

The U.S. Food and Drug Administration (FDA) has assigned a Class I classification to Medline’s recall of endotracheal tubes following reports of device failures.

Class I represents the agency’s most serious recall designation, meaning continued use of the products without action could result in serious injury or death.

Medline has issued a customer notice regarding the Sub-G Endotracheal Tube with Subglottic Suction Device, requiring the destruction of all affected stock.

According to the FDA’s recall database, 168,632 tubes and 13,092 kits are affected.

The devices help patients breathe by draining fluid from the top of the trachea. This tube keeps the airway open so that oxygen, medication, or anesthesia can be administered. The most common targets for Medline tubes include patients with pneumonia, heart failure and a collapsed lung. It is also used to remove blockages in the respiratory tract.

According to the FDA notice, the recall includes “removal of devices from places where they are used or sold.”

Access the most comprehensive company profiles on the market, powered by GlobalData. Save hours of research. Gain a competitive advantage.

Company Profile – free sample

You will receive a download email shortly

We are sure of the exceptional quality of our company profiles. However, we want you to make the most beneficial decision for your business, which is why we offer a free sample, which you can download by submitting the form below

By GlobalData







Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information about your rights in relation to your personal data and how you can unsubscribe from future subscriptions marketing messages. Our services are intended for corporate subscribers and you warrant that the email address you submit is your corporate email address.

Tubes are being recalled due to detachment or tearing of the inflation tube and major tube components. This causes the cuff to leak, accumulate moisture and fail to inflate.

The FDA has stated that if detachment occurs during therapy, airway obstruction and choking may occur. Reports also indicate that the main pipe is prone to tears and problems around the suction port connections.

The agency cited a number of serious health consequences from continued use of the device, including low oxygen levels, respiratory failure and cardiac arrest, among others. The recall notice also cited the potential for cerebral hypoxia, organ damage and death. There have been three reports of injuries caused by this device.

This is the second recall of Medline products in quick succession, after 1.5 million handrails manufactured by the company were recalled late last month. Two deaths were reported as a result of being trapped between the rails.