June 21, 2019
FDA MedWatch: Hudson RCI Sheridan and Sheridan Endotracheal Tubes by Teleflex Medical
TOPIC: Hudson RCI Sheridan and Sheridan Endotracheal Tubes by Teleflex Medical: Class I Recall - Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit
AUDIENCE: Anesthesiology , Critical Care Medicine, Emergency Medicine, Risk Manager, Surgery
ISSUE: Teleflex Medical is recalling multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to complaints of the Sheridan connector disconnecting from the breathing circuit. Each tracheal tube includes an appropriately sized 15mm connector. Although the connector can be removed, it should not disconnect from the endotracheal tube without significant force. Use of the affected devices may cause serious adverse health consequences, including disconnection from the breathing circuit which may result in insufficient oxygenation, and death.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.