Class I Recall of Teleflex Medical's Hudson RCI Sheridan and Sheridan Endotracheal Tubes
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.
Teleflex Medical has received 179 complaints with 192 occurrences in association with the ETT disconnection. This includes two deaths and one injury.
Recalled Product Information:
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:
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
- 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@example.com 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. 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
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