Teleflex Incorporated, a medical device manufacturer, ordered a recall of their Hudson RCI Sheridan Endotracheal Tubes. The tubes have been reported as a factor in four cases of deaths and several cases of severe injury.
Endotracheal tubes are plastic tubes that are meant to facilitate the oxygen intake of patients in need of breathing support. The tubes are inserted into a patient’s windpipe and connected to ventilation machines, to assist with air intake. The Teleflex tubes were recalled based on reports that they can become disconnected from machines, and result in inadequate oxygen circulation for patients. The U.S. Food and Drug Administration (FDA) issued the recall under “Class I” status, which includes “situation[s] in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Patients who are currently using the recalled endotracheal tubes should stop their use of the device as soon as possible, and return the tubes to Teleflex or the platform from which they were purchased. According to the recall, the devices will be removed from any medical facilities or distributors where they are currently in supply. In any case of a medical device or pharmaceutical recall, it is important to discuss the implications of stopping use with a doctor.
The negligence of medical device manufacturers and regulatory agencies like the FDA can lead to hazardous defects that severely harm patients. If you were affected by the carelessness of a negligent party and were injured by the use of a defective medical device or other product, contact Samster Konkel & Safran
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