Notes

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

Avanos Medical has recalled Cortrak*2 EAS in response to reports of injuries and deaths from tube malfunctions.

The US Food and Drug Administration (FDA), has designated the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as an I class recall.

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

Avanos Medical pulled Cortrak* 2 EAS from service after death and injuries of patients due to nasogastric tube misplacements.

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

Avanos Medical feeding tube But, the incorrect placement of the nasogastric, or nasoenteric tube could cause serious injury or even death.

The company recalls 629 devices sold throughout the US between January 2016 to January 2022.

Avanos Mediacal Cortrak 2 feeding tube placement The company also noted in a recall announcement that there have been more than 23 patients and 60 injuries that died in 2015 as a result of the incorrect placement of nasogastric feed tubes when using the Cortrak* 2 EAS.

Avanos Medical will revise the labelling after the recall. This will include updated instructions regarding the use and intended uses of Cortrak*2 EAS.

The updated guidelines instruct users to ensure that the tube is placed according to the protocols of the institution before to its use.

Avanos Medical feeding tube Avanos Medical has its headquarters in Alpharetta Georgia. The company markets its recognised brands in over 90 countries.

https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ The company signed an agreement to purchase OrthogenRx for $160 million in December. Avanos Medical concluded the acquisition on the 20th of January.


Here's my website: https://www.medscape.com/viewarticle/891200