Class I Recall: Teleflex Medical’s Hudson RCI Sheridan and Sheridan Endotracheal Tubes

The Food and Drug Administration has identified the Hudson RCI Sheridan and Sheridan Endotracheal Tubes from Teleflex Medical a Class I recall, the most serious type of recall, due to risk of the Sheridan connector disconnecting from the breathing circuit. Endotracheal tubes (ETT) are devices used for opening a patient’s airway, ventilation, and administering anesthesia. ETTs are used when a patient cannot breathe on their own, often during surgical procedures that use inhaled anesthetic gases.

FDA announced in a release that 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. Teleflex Medical has received 179 complaints with 192 occurrences in association with the ETT disconnection. This includes two deaths and one injury.

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.

Select Sheridan branded Endotracheal Tubes and Connectors EIF-000361. Product sizes 6.0, 6.5, 7.0, 7.5, 8.0 and 8.5 mm are included in this recall.

Specific Lots include Hudson RCI Sheridan LTS, Hudson RCI Sheridan (CF, Preformed, HZT) 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 mm, Hudson RCI Sheridan/EZ-ENDO 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 mm, Hudson RCI Sheridan Uncuffed 6.0, 6.5, 7.0 mm, Sheridan/CF Novaplus 7.0, Sheridan/HVT Novaplus 7.0, 7.5, 8.0, 8.5 mm (see a full list of affected devices).

Distribution Dates: October 2016 to May 2019, Devices Recalled in the U.S.: 6,067,502

Date Initiated by Firm: May 22, 2019

On May 24, 2019, Teleflex Medical issued an Urgent Recall Notification instructing customers to:

·   INSPECT your inventory for the affected product codes identified above. If you have affected stock in inventory, immediately discontinue use and quarantine the products.

·   NOTIFY Teleflex. Please complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected] or hand it to your sales representative.

·   RETURN the affected product. A customer service representative will contact you with a Return Goods Authorization (RGA) number covering your inventory and provide instructions for the return of products.

For questions or concerns regarding this notification, please call Teleflex Customer Service at 1-866-396-2111.