FDA has identified Avanoss Cortrak2 EAS recall as Class I

Avanos Medical recalls Cortrak*2 EAS following reports of injuries and even death caused by tube malfunctions.

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

A Class I recall is a reference to the most severe of the three classes.

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

The device is able to assist healthcare professionals to insert medical feeding tubes in patients. Avanos Mediacal Cortrak 2 Avanos Medical feeding tube It also provides real-time details about the placement of tubes.

However, improper placement of nasogastric/nasoenteric tubs can result in severe injuries or even death.

The company recalls 629 units, which were distributed in the US from 1 April 2016 until 1 January 2022.

The recall notice from the company stated that 60 patients were injured and 23 of them died as a result of the wrong placement of nasogastric tubes when using Cortrak* 2 EAS.

Following the recall Avanos Medical will update the labeling of the device. This will include an update of the instructions and the planned applications for Cortrak* 2 EAS.

The revised guidelines require users to verify the location of tubes according to protocols issued by their institutions prior to making use of them.

Avanos Medical, based in Alpharetta Georgia America, is a manufacturer of medical devices that are clinically proven. The brand's name is accessible in over 90 countries.

In December of last year the company signed an agreement of $160 million to acquire OrthogenRx. Avanos Medical completed the acquisition on January 20.

Cortrak 2 eternal access system