FDA Orders Immediate Recall of Cuffed Tracheostomy Tubes

The U.S. Food and Drug Administration (FDA) has recalled a defective medical device that is used for patient ventilation in hospitals throughout the country. The Covidien Shiley Adult Tracheostomy Tube is suspected of leaking and/or coming disconnected, potentially causing complications for patients.

The recall is a class I, which means that the products being recalled poses a risk of severe injury or even death. A class I recall is the most serious of those the FDA issues.

Two lots have been recalled and both were made and sold from Oct. 1, 2009 to June 26, 2012. The recall was prompted by complaints from hospital customers.

The FDA and Covidien, the company selling the device, are urging customers to return all of the faulty medical devices that are not currently in use and to closely watch any patients currently using the tube. They also urge all users to remove and replace the defective device as soon as it is clinically advisable to do so.

A tracheostomy tube is used to provide a pathway in the windpipe for fluid from the lungs and trachea to drain. This device is commonly used to make it possible for patients to breathe when they are unable to do so without assistance.

Covidien has its headquarters in Mansfield, Massachusetts. According to company representatives, the lots being recalled are Shiley size 8 adult reusable, cuffed tracheostomy tubes. Covidien says that no other sizes or styles of the device are part of the recall.

Covidien is working to provide replacement tubes and will have them available soon.

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