Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit

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: 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 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 Device Use: 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. Reason for Recall: 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...
Source: JEMS Operations - Category: Emergency Medicine Tags: News Patient Care Operations Source Type: news