UNITED STATES – According to an online report at FDA.gov, Teleflex Medical has issued a Class I recall (the most serious type of recall in the United States) of numerous models of the Sheridan Endotracheal Tubes and the Hudson RCI Sheridan due to the fact that they have been disconnecting from the breathing circuit that they are attached to.
Endotracheal tubes (ETTs) are used to open a person’s airway, administer anesthesia, and for ventilation. ETTs assist people in breathing when they cannot do so on their own.
The Recalled Products
- 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
The Reasons for the Recall
Teleflex Medical has issued a recall of the models of ETTs listed above due to serious issues associated with the Sheridan connector disconnecting from the breathing circuit. Each ETT includes a 15 mm connector, which can be removed however, it should take significant force to do so.
Using defective ETTs may cause serious health consequences, including a disconnection from the breathing circuit that could result in a lack of oxygen and even death. Thus far, Teleflex Medical has received 179 complaints and 192 issues where the ETT became disconnected from the breathing circuit. There were two deaths and one injury reported thus far.
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