Teleflex Medical has issued a recall for the Willy Rusch Tracheostomy Tube Set because 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, the patient may not receive adequate ventilation and would need immediate medical intervention including changing the tracheostomy tube and placing a new tube. Use of the recalled devices products may cause serious adverse health consequences including oxygen deprivation, brain damage, and death.
The Food and Drug Administration (FDA) has classified this recall as a Class I recall, the agency’s most serious recall category. Use of the affected devices may cause serious injury or death.
The recalled tracheostomy tube set is the Willy Rusch TracheoFlex Tracheostomy Tube Set, lot numbers 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491; product codes 120502-000030, 120502-000040, 120502-000050, 120502-000060, 858121-000050, 858121-000060. The sets were manufactured between June and December 2015 and were distributed nationwide from July 2015 until May 2016.
A tracheostomy tube is a single-use device that is placed through the patient’s windpipe (trachea) during a surgical procedure called a tracheostomy. The tracheostomy creates a safe airway access and provides a pathway to remove fluid from the trachea and lungs, the FDA explains.
On August 26, 2016, Teleflex Medical sent an Urgent Field Safety Notice to all affected customers. Customers were asked to identify and quarantine any affected devices in their inventory and to contact customer service for instructions about how to return the affected devices to Teleflex. Customers may also contact their local sales representative. Teleflex (or the local dealer) will issue a credit on receipt of the returned tracheostomy sets.
Health care professionals and customers with questions about the recall should contact their sales representative or call Customer Service at 866-246-6990.