A Class I recall of 6 million Teleflex (NYSE:TFX) Sheridan endotracheal tubes and connectors indicated for use on patients under general anesthesia has expanded to include connector kits manufactured by Centurion Medical Products, according to the FDA.
Teleflex began recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes in June 2019 due to complaints of the Sheridan connector dislodging from the endotracheal tube and disconnecting the patient from the breathing circuit. This may result in insufficient oxygenation, decrease in vital signs, or death.
The number of deaths reported to Teleflex since the initial recall has risen from two to four, along with 18 injuries. However, Centurion has not received any complaints or reports of deaths or injuries related to the Teleflex recalled product, according to the FDA. The 80 recalled Centurion kits, which carry the model number TC7855, were distributed from November 28, 2018, to June 5, 2019.
Centurion issued a customer notification letter on July 3, 2019, to Medline, its parent company and sole customer for this product, to instruct affected customers to return the kits.