Notes

FDA has identified Avanos Medical’s Cortrak*2 EAS recall Class I

Avanos Medical called off Cortrak* 2 EAS in response to the patient death and injuries caused by tube misplacements.

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

Avanos Medical A Class I Recall is the most serious one out of the three classes.

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

Avanos Medical feeding tube The device is intended to aid health care professionals to place medical feeding tubes onto patients.

However, incorrectly installed nasogastric/nasoenteric pipe can cause damage to the vocal cords or the trachea. Avanos Mediacal Cortrak 2 This could lead to grave injuries or even death.

The company has since removed 629 devices from the US which were distributed between April 1st, 2016 and 1 January 2022.

According to the company's recall notice the company's recall communication, there were 53 deaths and 60 injuries in 2015 as a result of the misplacement of nasogastric tube feeding tubes in the course of using the Cortrak* 2 EAS.

Avanos Medical is updating the marking on the device following the recall. This will include updating the instructions on how to use the device and the intended use of the Cortrak*2 EAS.

Avanos Medical These revised guidelines direct users to check the placement of tubes according to the institution's protocols prior to using the tube.

Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on making medical devices for clinical use. The company sells its recognized brands across more than 90 countries.

The company came to an agreement with OrthogenRx to acquire the company in a $160m deal. Avanos Medical closed on the acquisition in January.


Here's my website: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm