Notes

FDA has classified Avanos Medical's Cortrak*2 EAS recall as Class 1

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

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

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system The term "Class I Recall" is a reference to the most severe of three classes.

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

The device was developed to assist trained health professionals in putting medical feed tubes into patients.

https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ But, incorrect positioning of nasogastric/nasoenteric tubes can cause severe injuries, or even death.

The company is recalling 629 devices, which were distributed in the US from April 1st, 2016 until 1 January 2022.

The company also noted in a recall communication that there have been 60 injuries and 23 patients that died in 2015 as a result of the misplacement nasogastric feed tubes that were connected to the Cortrak* 2 EAS.

Cortrak 2 eternal access system Cortrak 2 eternal access system Avanos Medical will revise the labelling in the wake of the recall. This will include updated instructions for use and intended usages of Cortrak*2 EAS.

The revised guidelines also direct users to verify the placement of their tubes in accordance with the institution's guidelines prior to using.

Avanos Medical's headquarters is located in Alpharetta Georgia America. They specialize in manufacturing medical equipment. Avanos Medical sells its products across more than 90 countries.

Last December the company signed an agreement worth $160 million to acquire OrthogenRx. Avanos Medical completed the acquisition on the 20th of January.

Avanos Medical feeding tube
My Website: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm