FDA classifies Avanos Medicals Cortrak2 EAS recall as Class I

Avanos Medical pulled Cortrak*2 EAS off service following reports of deaths and injuries related to tube missing.

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview 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.

The most severe of the three kinds is the Class I recall.

Avanos Mediacal Cortrak 2 Avanos Medical recalls Cortrak*2 EAS after reports of injury and deaths due to incorrect placements of nasogastric or nasal tubes.

Cortrak 2 eternal access system The device was designed to assist healthcare professionals with training to insert medical tube feedings within patients, and provide the most current information about tube placement.

However, incorrectly placed nasogastric/nasoenteric pipes could result in damage to vocal cords and trachea. Cortrak 2 eternal access system This could lead to serious injuries or even death.

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

According to the company's recall notice it was reported that there were sixty injuries and 23 deaths during 2015 because of the misplacement of nasogastric tube feeding tubes when using the Cortrak* 2 EAS.

Following the recall, Avanos Medical will update the labeling of the device. feeding tube placement This includes updating the instructions for use , as well as intended uses of Cortrak*2 EAS.

These revised guidelines direct users to ensure that the tube is placed according to the institution's protocols prior use.

The headquarters are located in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. The company's recognized brands are available in over 90 countries.

https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system The company signed a $160 million agreement in December of last year to acquire OrthogenRx. Avanos Medical concluded the acquisition on January 20th.