Notes

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

Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and deaths due to tube misplacements.

The US Food and Drug Administration has classified Avanos Medical’s Cortrak*2 Enteral Access System (EAS), as a Class 1 recall.

A Class I remember is considered to be to be the most important of the three classes.

Avanos Medical pulled Cortrak* 2 EAS out of service due to patient deaths and injuries due to misplacements of nasogastric tubes.

Avanos Medical The device was designed to aid trained health care professionals when placing medical feed tubes in patients.

However, the incorrect placement of the nasogastric or nasoenteric tube could result in severe injuries or even death.

Avanos Medical feeding tube The recall covers 629 devices that were available in the US between February 1st, 2016 and 1 January 2022.

Avanos Medical feeding tube According to the recall announcement issued by the company, there were sixty injuries and 23 deaths in 2015 due the incorrect placement of nasogastric feeding tubes when using the Cortrak* 2 EAS.

Avanos Medical will make the needed changes to the labeling of the device in the wake of the recall. This will include updated instructions on how to use the device and the intended use of Cortrak*2 EAS.

The revised guidelines also require users to ensure that the tube is placed according to the institution's protocols before usage.

Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on making medical devices for clinical use. https://en.wikipedia.org/wiki/Avanos_Medical Avanos Medical has over 90 markets for its recognized brands.

feeding tube placement Avanos Medical feeding tube Last December, the business signed an agreement to acquire OrthogenRx in an agreement worth $160 million. Avanos Medical completed the acquisition on January 20.

feeding tube placement
My Website: https://en.wikipedia.org/wiki/Avanos_Medical