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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

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

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.