June 26, 2019 — Teleflex Inc. has issued a Class 1 recall for certain Hudson RCI® Sheridan® Endotracheal Tubes.
At least 4 patients died and other patients suffered serious injuries when a connector disconnected from the endotracheal tube, resulting in loss of oxygenation and the need for emergency medical intervention.
The recall involves specific lots of the 15-mm Sheridan connector that were distributed from October 2016 to May 2019.
Use of the device poses a risk of severe injury or death:
“The immediate consequence for patients is disconnection from the breathing circuit, which may result in insufficient oxygenation, requiring medical intervention.”
The recall has been designated as a Class 1 recall by the FDA. This is the most serious type of recall, reserved for situations when using the recalled device poses a reasonable risk of causing injury or death to a patient.
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