Medical device recall

Following Two Deaths, Teleflex Medical Recalls More than Six Million Endotracheal Tubes and Connectors

By MedTech Intelligence Staff
No Comments
Medical device recall

The Class I recall involves complaints that the connector disconnects from the breathing unit.

Teleflex Medical has recalled more than six million endotracheal tubes (ETT) and connectors. ETT devices are used to open a patient’s airway, and for ventilation and administering anesthesia. The problem with the recalled products is that the Sheridan connector has been disconnecting from the breathing unit in some instances, and without significant force.

Thus far, the company has received 179 complaints about the issue, which affects certain Sheridan-branded ETT products, with 192 occurrences associated with the disconnection of the endotracheal rube, including one injury and two deaths.

The FDA has a full list of the devices that are part of this Class I recall listed on its website. The company’s 6,067,502 recalled devices were distributed in the United States between October 2016 and May 2019. Teleflex initiated the recall on May 22and issued an Urgent Recall Notification to customers to discontinue use of and quarantine the products.

Leave a Reply

Your email address will not be published. Required fields are marked *