FDA classifies Avanos Medical's cortrak*2 EAS recall as Class 1.

Avanos Medical recalled Cortrak* 2 EAS in the wake of reports of injuries and patient deaths caused by tube malfunctions.

https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement The US Food and Drug Administration (FDA) has designated the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as an class I recall.

A Class 1 recall is the most serious of the three classes.

Avanos Medical pulled Cortrak* 2 EAS out of service due to patient deaths and injuries due to nasogastric tubes misplacements.

Avanos Medical feeding tube The device allows trained healthcare professionals to insert medical feeding tubes in patients.

However, incorrectly placed nasogastric/nasoenteric pipes could cause harm to the vocal cords and the trachea. This could lead to grave injuries or even death.

The recall covers 629 devices that were sold in the US between 1 February 2016 until 1 January 2022.

Avanos Medical The company also noted in a recall announcement that there have been more than 23 patients and 60 injuries who died since 2015 due to the incorrect placement of nasogastric feed tubes when using the Cortrak* 2 EAS.

Avanos Medical is updating the labelling on the device after the recall. This will include changing the instructions as well as the intended applications for Cortrak* 2 EAS.

The updated guidelines require users to confirm the placement of tubes based on protocols issued by their institutions prior to making use of them.

Avanos Medical is based in Alpharetta (Georgia) in the United States. It specializes in the production of medical devices.  Avanos Medical The company markets its recognised brands in more than 90 countries.

Last December, the business entered into an agreement to buy OrthogenRx in the amount of $160 million. Avanos Medical closed the acquisition on 20 January.