Notes

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

Avanos Medical called off Cortrak* 2 EAS as a result of patient death and injuries caused by tube displacements.

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

The most serious of the three kinds is a Class I remember.

Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths from nasogastric tube misplacements.

Avanos Medical The device was designed to aid healthcare professionals with training to insert medical feeding tubes in patients and offer real-time location information on tube placement.

Avanos Mediacal Cortrak 2 A wrong placement of the nasogastric and nasoenteric tube can result in serious injuries or death.

https://controlc.com/54fdf286 https://penzu.com/p/9b273795 The company has recalled 629 devices throughout the US between January 2016 and January 2022.

The recall communication from the company stated that there were more than 23 patient deaths since 2015 due to misplacement of the nasogastric feeding tubes when using the Cortrak* 2 EAS.

Avanos Medical feeding tube Avanos Medical is updating the marking on the device following the recall. This includes an update of the instructions on use and intended use of Cortrak* 2 EAS.

Users are also directed to confirm that the tubes have been installed in accordance with the protocols of the institution before they utilize them.

Avanos Medical is based in Alpharetta (Georgia) in the United States. Its focus is on manufacturing medical equipment. Its brands are available across more than 90 countries.

In December, the company entered into an agreement of $160 million to acquire OrthogenRx. Avanos Medical concluded the acquisition on January 20th.


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