Notes

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

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

Avanos Medical The US Food and Drug Administration has identified the Cortrak*2 of Avanos Medical's enteral access system (EAS), for recall as Class II recall.

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

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

The device is designed to aid health care professionals to place medical feeding tubes for patients.

A wrong placement of the Nasogastric tube and nasoenteric tube could cause serious injury or even death.

Avanos Medical Overall, the company has recalled 629 devices that were sold in the US between April 1st, 2016 to 1 January 2022.

Avanos Medical feeding tube placement According to the company's recall communication it was reported that there were sixty injuries and 23 deaths during 2015 because of the incorrect placement of nasogastric feeding tubes when using the Cortrak* 2 EAS.

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

Avanos Medical feeding tube The updated guidelines instruct users to verify tube placement in accordance with the protocol of the institution's prior use.

Avanos Medical, based in Alpharetta Georgia in the United States is a producer of medical devices that are clinically proven. Cortrak 2 eternal access system It sells its brands in over 90 different countries.

In December of last year, the company signed an agreement to acquire OrthogenRx in the amount of $160 million. Avanos Medical successfully closed the acquisition of OrthogenRx in January.


Homepage: https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/