Teleflex Incorporated is recalling more than six million Hudson RCI@ Sheridan-brand endotracheal tubes (ETT) and connectors after receiving dozens of reports that the devices have malfunctioned, which has contributed to four deaths as well as some serious injuries.
Endotracheal tubes are devices used to open a patient’s airway, or for ventilation and administering anesthesia. They are used when a patient cannot breathe on his own, often during surgical procedures that use inhaled anesthetic gasses.
The recall was initiated because the connector can disconnect from the breathing unit. The connector (which is about 15mm in size) can be removed, but it should not disconnect from the endotracheal tube without significant force. But, in some cases, the connector disconnected from the breathing unit without significant force. If this occurs, patients are at risk for insufficient oxygenation and could require medical intervention.
Teleflex Medical initially reported received 172 complaints about the issue with 192 occurrences in which the ETT disconnected, resulting in two deaths and one injury. The company later reported four deaths as well as additional serious injuries where ETT disconnection was a factor.
The Food and Drug Administration (FDA) has classified the recall as a Class I, which is reserved for situations in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Affected devices were distributed October 2016 to May 2019. A full list of recalled Teleflex Endotracheal Tubes can be found here.