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

Avanos Medical has recalled Cortrak*2 EAS because of reports of injuries and deaths caused by tube misplacements.

The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak* 2 Enteral Access System (EAS) as Class I recall.

The most severe of the three types is a Class I can remember.

Avanos Medical called off Cortrak*2, EAS, due to deaths and injuries resulting from the misplacement of nasogastric tubs.

Avanos Medical The device allows healthcare personnel to place medical feeding tubes inside patients.

However, incorrectly placed nasogastric/nasoenteric pipes can cause damage to the vocal cords or the trachea. This can lead to severe injuries, or even death.

https://www.transtats.bts.gov/exit.asp?url=https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html Avanos Medical feeding tube Cortrak 2 eternal access system The company has recalled 629 devices throughout the US between January 2016 to January 2022.

The company also stated in a recall notice that there had been more than 23 patients and 60 injuries that died in 2015 as a result of the misplacement nasogastric feed tubes when using the Cortrak* 2 EAS.

Avanos Medical is updating the marking on the device following the recall. Avanos Medical feeding tube This will include changing the instructions for Cortrak*2 EAS as well as its expected uses.

The updated guidelines instruct users to ensure that the tube is placed according to the protocols of the institution before to use.

Avanos Medical, based in Alpharetta Georgia America is a producer of medical devices that are clinically proven. Avanos Medical's well-known brands are available in over 90 countries.

The company signed a $160m agreement last December to acquire OrthogenRx. Avanos Medical concluded the acquisition on the 20th of January.


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