The Food and Drug Administration (FDA) has recently issued a class 1 recall of certain tracheostomy tubes because there were complaints of leaking and disconnection malfunctions. These tubes are used to perform the surgical procedure tracheotomy. These tubes are inserted into the trachea through an incision in the back of the neck. These tubes are essential so that the patients can keep breathing without the use of their nose or mouth. Specifically, the tubes being recalled are the size 8 adult Covidien Shiley Tracheostomy Tubes.
During a medical procedure, this may cut off a patient's airway and make it difficult for them to breathe. The recalled batches of these tubes were distributed to hospitals from October 2009 to June 2012. These are the only tubes that are subject to recall and pose a risk of danger for patients. If it is not possible for hospitals to quickly replace these defective tubes, they can still be used, but only under intense supervision by hospital staff. Typically, the product manufacturer will issue the recall if they were the ones to discover a possible defect with their device. In this instance, the FDA issued the recall and the manufacturer complied, which is fairly typical with class 1 recalls.
There are three major classes of recalls: 1 through 3. Class 3 is for products that are unlikely to cause harm, but have still been shown to be defective and not meet FDA standards. Class 2 recalls are for products that may cause patients harm or a slight threat and Class 1 recalls are for those products that are deemed dangerous and could cause serious injury or death. Any patients who are injured by these defective tracheostomy tubes may have a case on their hands. The FDA ruled that these products were dangerous and should not be used for risk of injury.
Contact Arnold & Itkin today to discuss your case.