Class 1 Recall: TeleFlex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Patient Use
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
A tracheostomy tube is a single-use device that is placed through the patient’s windpipe (trachea) during a surgical procedure called a tracheostomy to create safe airway access and provide a pathway to remove fluid from the trachea and lungs.
Reason for Recall
Teleflex is recalling the Willy Rusch Tracheostomy Tube Set due to the possibility that the connector may disconnect from the tracheostomy tube during use on a ventilated patient. If the connector detaches from the tracheostomy tube shaft during use, it can deprive the patient of adequate ventilation and would require immediate medical intervention including changing the tracheostomy tube and placing a new tube. The use of affected products may cause serious adverse health consequences including oxygen deprivation, brain damage and death.
Who May be Affected
What to Do
On August 26, 2016, Teleflex Medical sent an "Urgent Field Safety Notice" to all affected customers. The notice asked customers to:
Health care professionals and customers with questions are instructed to contact their local sales representative or Customer Service at 866-246-6990, with any questions related to this recall.
Date Recall Initiated:
August 26, 2016.