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FDA confirms the Avanos Medical Cortrak* 2 EAS recall as Class I

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

https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html The US Food and Drug Administration has identified Avanos Medical’s Cortrak*2 enteral access system (EAS) as a recall as a Class II recall.

The term "Class I Recall" is a reference to the most severe of three classes.

Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths caused by misplacements of nasogastric tubes.

The device allows trained health professionals to insert medical feeding tubes in patients.

However, the incorrect placement of the nasogastric or nasoenteric tubes could cause serious injury or even death.

The company has since been able to recall 629 devices in the US that were distributed between April 1, 2016 and 1 January 2022.

The company also stated in a recall communication that there had been 60 injuries and 23 patients that died in 2015 as a result of the incorrect placement of nasogastric feed tubes in the Cortrak* 2 EAS.

Avanos Medical is updating the marking on the device following the recall. Avanos Mediacal Cortrak 2 This will include updated instructions on how to use the device and the intended use of the Cortrak*2 EAS.

Users are also directed to ensure that the tubes are installed in accordance with the protocols of the institution before they use.

Avanos Medical Avanos Mediacal Cortrak 2 Avanos Medical is based in Alpharetta (Georgia) in the United States. It is a specialist in manufacturing medical equipment. Avanos Medical has over 90 markets that are branded with its brands.

Avanos Medical feeding tube The company reached an agreement with OrthogenRx to purchase the company for $160 million in a deal. Avanos Medical completed the acquisition on the 20th of January.


My Website: https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/
     
 
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