Notes

FDA has classified Avanos Medical's Cortrak*2 EAS recall as Class I

Avanos Medical has recalled Cortrak*2 EAS because of reports of deaths and injuries from tube displacements.

The US Food and Drug Administration has recognized Avanos Medical's Cortrak*2 enal Access System Recall (EAS) in a Class I recall.

A Class I remember is the most serious type out of the three classes.

feeding tube placement Avanos Medical recalls Cortrak*2 EAS after reports of injury and death due to misplacements of nasogastric or nasoenteric tubes.

The device is intended to assist health professionals put medical feed tubes onto patients.

Avanos Mediacal Cortrak 2 However, the incorrect positioning of the nasogastric or nasoenteric tube could result in severe injuries or even death.

Avanos Medical The recall affects 629 devices that were sold in the US between 1 February 2016 and 1 January 2022.

The recall notification from the company said that 60 patients suffered injuries and 23 were killed due to the wrong placement of nasogastric tubes when making use of Cortrak* 2 EAS.

Avanos Medical, following the recall, will update the device's labelling. Avanos Medical feeding tube This will include updating instructions regarding the use and intended uses of the Cortrak*2 EAS.

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview Users are also directed to ensure that the tubes are installed in accordance with the protocols of the institution prior to use.

Avanos Medical has its headquarters in Alpharetta Georgia. The company sells its brands across more than 90 countries.

Last December, the company signed an agreement to acquire OrthogenRx in an agreement worth $160 million. Avanos Mediacal Cortrak 2 Cortrak 2 eternal access system Avanos Medical concluded the acquisition on 20th January.


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