May 26, 2010: Recall Update Shiley™ Tracheostomy Tubes
On May 17
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.
In April,
FDA and Covidien notified customers and healthcare professionals of a voluntary
recall of certain lots of the cuffed
ShileyTM 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.
The Law
Firm of Eric H. Weinberg has been successfully litigating pharmaceutical drug
and medical device cases for over twenty years. If you or a loved one have been injured by a defective
medicine or medical device, and you have a question about your legal rights,
you can request a Free Case Evaluation . You may also contact us toll free at
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