According to an FDA alert, Centurion Medical Products has issued a Class I Recall for its Airway Kit containing Sheridan Endotracheal Tubes, which were previously recalled by Teleflex.
On May 30, 2019, Teleflex recalled multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to reports of the Sheridan endotracheal tube connector dislodging from the endotracheal tube, causing disconnection of the patient from the breathing circuit, which may result in insufficient oxygenation, decrease in vital signs, or death, according to the FDA.
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
- Recalled Product
- Airway Kit containing Sheridan® Endotracheal Tubes
- Model numbers: Kit TC7855
- Distribution Dates: November 28, 2018 to June 5, 2019
- Devices Recalled in the US: 80 kits
- Date Recall Initiated: June 7, 2019
The airway kits contain endotracheal tubes to open the patient’s airway, provide ventilation, and administer anesthetic gas when a patient cannot maintain adequate respiratory function to meet their needs, such as while under general anesthesia during a surgical procedure.
Teleflex informed Centurion of its recall for select Sheridan Endotracheal Tubes and Connectors, as Centurion includes the recalled product in their convenience kit.
Four deaths and 18 injuries have been reported to Teleflex in association with disconnection. However, Centurion has not received any complaints or reports of deaths or injuries related to the Teleflex recalled product.
The use of affected product may cause serious adverse health consequences, including death, for patients who had procedures under general anesthesia from November 28, 2018, to June 5, 2019, involving Centurion’s Airway Kit containing Teleflex/Sheridan endotracheal tubes.
Centurion issued a customer notification letter on July 3, 2019, to Medline, the parent company and sole customer for this product, to communicate with affected customers, instructing customers to identify affected product in inventory and return the affected product.
Customers with questions about this recall may contact Centurion Medical Products Corp at 517-545-1156.