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

Avanos Medical has recalled Cortrak*2 EAS in response to reports of deaths and injuries from tube malfunctions.

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

https://wowservices.info/index.php?page=search&sCategory=76 https://bbs.pku.edu.cn/v2/jump-to.php?url=https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ The Class 1 recall is the most severe of the three classes.

Avanos Medical recalled Cortrak* 2 EAS following reports of injuries and patient deaths due to nasoenteric or Nasogastric tube malfunctions.

https://www.fcc.gov/fcc-bin/bye?https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm The device is intended to assist health professionals put medical feed tubes onto patients.

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

Overall, the company has been able to recall 629 devices sold across the US between April 1st, 2016 and 1 January 2022.

According to the recall announcement issued by the company the company's recall communication, there were 53 deaths and 60 injuries in 2015 as a result of the misplacement of nasogastric tube feeding tubes during use of the Cortrak* 2 EAS.

Avanos Medical is updating the marking on the device following the recall. https://portal.sumdu.edu.ua/question/avanos-recalls-cortrak-2-over-potential-enteral-tube-misplacement-2 This includes an update of the instructions and the planned uses for Cortrak* 2 EAS.

The revised guidelines require users to confirm the placement of tubes according to protocols from their respective institutions before using the tubes.

The headquarters are located in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. The company operates in more than 90 markets for its recognized brands.

Avanos Medical The company agreed to buy OrthogenRx at $160 million during December. Avanos Medical closed the acquisition on the 20th of January.


Website: https://bbs.pku.edu.cn/v2/jump-to.php?url=https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
     
 
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