FDA: Class I recall of Willy Rusch Tracheostomy Tube Set

Editor's Note

The Food and Drug Administration (FDA) on October 20 categorized the recall by TeleFlex Medical of its Willy Rusch Tracheostomy Tube Set as Class I, the most serious.

The recall was issued because of the possibility that the connector may disconnect from the tracheostomy tube during use on a ventilated patient.

If the connector detaches, it can deprive the patient of adequate ventilation, causing serious adverse consequences, including oxygen deprivation, brain damage, and death.

Posted 10/20/2016] AUDIENCE: Risk Manager, Surgery ISSUE: 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.