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FDA announces the Cortrak*2 of Avanos Medical's EAS Recall Class I

Avanos Medical recalls Cortrak*2 EAS in the wake of reports of injury and death due to tube malfunctions.

https://peatix.com/user/12824958 The US Food and Drug Administration has identified the Cortrak*2 of Avanos Medical's enteral access system (EAS) as a recall as an Class II recall.

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

Avanos Medical recalled Cortrak* 2 EAS following incidents of injury and deaths due to nasoenteric Nasogastric tube malfunctions.

The device is able to assist health care professionals in placing medical feeding tubes in patients. It also gives real-time information regarding tube placement.

However, the wrong placement of the nasogastric or nasoenteric tube could cause severe injury or death.

feeding tube placement Overall, the company recalls 629 devices sold in the US between April 1st, 2016 and 1 January 2022.

The company also stated in a recall communication that there have been 60 injuries and 23 patients killed since 2015 because of the feed tubes that were not properly placed when using the Cortrak* 2 EAS.

Avanos Medical is updating the labels on the device following the recall. Avanos Medical feeding tube This includes updating the directions on how to use the device as well as intended uses of Cortrak*2 EAS.

Users should also confirm that the tubes have been put in the correct manner according to the guidelines of the institution before they make use of them.

Avanos Medical's headquarters are located in Alpharetta Georgia USA. They focus on the manufacturing of medical devices. Avanos Medical sells its products in more than 90 different countries.

Cortrak 2 eternal access system In December, the company entered into an agreement worth $160 million to purchase OrthogenRx. Avanos Medical closed on the acquisition in January.

Avanos Medical feeding tube
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