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
- Airway Kit containing Sheridan® Endotracheal Tubes
- Model numbers: Kit TC7855
- Distribution Dates: November 28, 2018 to June 5, 2019
- Devices Recalled in the U.S.: 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.
Reason for Recall
Teleflex informed Centurion of its recall for select Sheridan® Endotracheal Tubes and Connectors, as Centurion includes the recalled product in their convenience kit. 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.
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.
Who May be Affected
- 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.
- Health care providers, distributors, and facilities using Centurion’s Airway Kit containing Teleflex/Sheridan® endotracheal tubes.
What to Do
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
- Return affected product
Customers with questions about this recall may contact Centurion Medical Products Corp. at 517-545-1156.
- Recall Database Entry
- Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit (classified June 21, 2019)
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.