Notes

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

Avanos Medical recalled Cortrak* 2 EAS after reports of injuries and deaths due to tube malfunctions.

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

A Class I Recall is the most serious type of the three classes.

Avanos Medical recalls Cortrak*2 EAS after reports of injuries and even death caused by incorrect placements of nasogastric or nasal tubes.

The device allows skilled healthcare professionals to insert medical feeding tubes in patients.

But, the incorrect placement of the nasogastric, or nasoenteric, tubes can cause severe injury or death.

Avanos Mediacal Cortrak 2 Avanos Medical The company has recalled 629 devices distributed throughout the US between January 2016 to January 2022.

According to the company's recall notice the company's recall communication, there were 60 injuries and 23 deaths in 2015 as a result of the incorrect placement of nasogastric feeding tubes when using the Cortrak* 2 EAS.

Avanos Mediacal Cortrak 2 In the wake of the recall Avanos Medical will update the device's labelling. This will include updating the instructions regarding the use and intended uses of the Cortrak*2 EAS.

Avanos Medical The new guidelines direct users to confirm that the tube was set up according to the protocol of the institution before to use.

Avanos Medical feeding tube Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. Avanos Medical markets its well-known brands across over 90 countries.

Last December, the company reached an agreement to purchase OrthogenRx in the amount of $160 million. Avanos Medical closed on the acquisition in January.


Read More: http://sc.sie.gov.hk/TuniS/www.weitzlux.com/firm-news/cortrak2-enteral-access-system/