Notes

FDA classifies Avanos Medical's Cortrak*2 EAS recall as Class 1.

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

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

The Class 1 recall is the most severe of three classes.

Avanos Medical feeding tube feeding tube placement Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and deaths due to nasoenteric or nasogastric tube misplacements.

This device can be used to aid trained healthcare professionals to insert medical feeding tubes into patients. It also provides in real-time details about the placement of tubes.

However, the wrong placement of nasogastric or nasoenteric tubes could cause damage to the vocal cords of patients or trachea, lungs, or vocal cords and cause severe injuries or even death.

The company has recalled 629 devices throughout the US between January 2016 and January 2022.

The company also said in a recall notice that there had been 60 injuries and 23 patients that died in 2015 as a result of the misplacement nasogastric feed tubes that were connected to the Cortrak* 2 EAS.

Avanos Medical After the recall, Avanos Medical will update the labeling of the device. This will include updating instructions for use and intended usages of the Cortrak*2 EAS.

The revised guidelines also require users to ensure that the tube is placed according to the institution's guidelines prior to using.

Avanos Medical is based in Alpharetta (Georgia) in the United States. https://app.glosbe.com/profile/7050998732967382217 Its focus is on the production of medical equipment. Avanos Medical markets its well-known brands across over 90 countries.

The company agreed to acquire OrthogenRx for $160 million in December. Avanos Medical completed the acquisition on the 20th of January.

Avanos Mediacal Cortrak 2
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