FDA identifies Avanos Medical’s Cortrak* 2 EAS recall as Class I

The US Food and Drug Administration (FDA ) has identified the recall of Avanos Medical’s Cortrak* 2 Enteral Access System (EAS) as a Class I recall.

A Class I recall is the most serious type out of three classes.

Avanos Medical recalled Cortrak* 2 EAS following reports of injuries and patient deaths due to nasoenteric or nasogastric tube misplacements.

The device is designed to help trained health care personnel place medical feeding tubes in patients and offer real-time location information on tube placement.

However, the wrong placement of nasogastric or nasoenteric tubes can damage a patient’s vocal cords, lungs or trachea, resulting in serious injuries or death.

Overall, the company has recalled 629 devices that were distributed in the US between 1 April 2016 and 1 January 2022.

The recall communication from the company added that there have been 60 injuries and 23 patient deaths since 2015 due to misplacement of nasogastric feeding tubes while using the Cortrak* 2 EAS.

Following the recall, Avanos Medical will update the device’s labelling. This will include updating the instructions for use and intended uses of Cortrak* 2 EAS.

The revised guidelines also direct users to confirm tube placement based on the respective institution’s protocols before usage.

Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on manufacturing clinical medical devices. The company markets its recognised brands in more than 90 countries.

Last December, the company signed an agreement to acquire OrthogenRx in a $160m deal. Avanos Medical closed the acquisition on 20 January.