FDA announces the Cortrak*2 of Avanos Medical's EAS Recall Class I

Avanos Medical recalled Cortrak* 2 EAS after reports of injuries and patient deaths caused by tube misplacements.

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

The term "Class I Recall" is a reference to the most difficult of three classes.

Avanos Medical pulled Cortrak* 2 EAS off service following death and injuries of patients due to nasogastric tubes misplacements.

feeding tube placement The device is intended to aid healthcare professionals with training to insert medical feeding tubes inside patients.  Avanos Medical feeding tube It also provides the most current information about tube placement.

The wrong placement of nasogastric and nasoenteric tube can cause serious injury or even death.

In total, the company has been able to recall 629 devices sold across the US between 1 April 2016 and 1 January 2022.

The recall communication from the company also stated that there were more than 23 deaths of patients since the year 2015 due to the misplacement of Nasogastric feeding tubes that were used with the Cortrak* 2 EAS.

Avanos Medical will make the necessary changes to the labeling of the device following the recall.  https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause This will include an update of the instructions regarding the use and intended usage of Cortrak* 2 EAS.

The revised guidelines require that users confirm the placement of tubes according to protocols of their institutions prior to using the tubes.

Based in Alpharetta, Georgia, US, Avanos Medical focuses on making medical devices for clinical use. Avanos Medical has over 90 markets that are branded with its brands.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Last December, the business reached an agreement to purchase OrthogenRx with a $160m deal. Avanos Medical successfully closed the acquisition of OrthogenRx in January.