Tracheostomy Tube Recall Update – On May 17, 2010, the FDA released an update to the recent recall of Shiley™ Tracheostomy Tubes classifying the recall as Class 1. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Tracheostomy Tube Recall Information
In April, FDA and Covidien notified customers and healthcare professionals of a voluntary recall of certain lots of the cuffed Shiley tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. The affected lots were distributed between November 2008 and September 2009.
According to FDA, a tracheostomy is a surgical procedure to create an opening through the neck into the windpipe (trachea) and tracheostomy tubes are prescription devices used by the order of a physician, usually placed through the windpipe to provide an airway and to provide a pathway to remove fluid from the trachea and lungs. Inflatable cuff tracheostomy tubes have a soft balloon around the far end of the tube that is inflated to seal off the space between the wall of the windpipe and the tracheostomy tube during mechanical ventilation. The cuff prevents air from the ventilator from leaking around the tracheostomy tube and prevents injury to delicate tissue in the windpipe.
FDA explains that, in the affected units, if a cuff doesn’t hold, air ventilation will be adversely affected, which could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation, leading to serious injury or even death.
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