Covidien Recall Termed as Class I by FDA

Covidien LP (Nellcor Puritan Bennett Inc.) has recalled its tracheostomy tubes due to the risk of volume leakage and disconnection between the inner and outer cannulae, which could endanger a patient’s life.

The recalled products include Shiley size-8 adult, reusable, cuffed tracheostomy tubes that were manufactured between October 1, 2009, and June 26, 2012. The defects that lead to the recall were identified during mechanical ventilation of patients.

A tracheostomy tube is a device that is placed in the windpipe of patients, during surgery, in order to facilitate the removal of fluid from the trachea and lungs. Inflatable cuff tracheostomy tubes, the variant of tracheostomy tubes that has been recalled, have a balloon around one end of the tube which, through inflation, seals the gap between the tracheostomy tube and the wall of the trachea.

Any error during the surgical procedure is critical could lead to a patient’s death. Because of this, it has been classified as a Class I recall by the Food and Drug Administration.

An official from the Food and Drug Administration (FDA) advised consumers to return the defective tubes to Covidien. If they are being used on a patient then they should be replaced as soon as it is safe to remove them and such patients should be kept under direct observation.

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law today for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.