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

Avanos Medical has recalled Cortrak*2 EAS because of reports of deaths and injuries caused by tube malfunctions.

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

Avanos Medical feeding tube The Class 1 recall is the most severe of three classes.

Avanos Medical Avanos Medical recalls Cortrak*2 EAS following reports of injuries and even death caused by incorrect placements of nasogastric or nasal tubes.

Avanos Medical The device was created to assist trained health professionals in putting medical feed tubes into patients.

However, incorrectly placed nasogastric/nasoenteric tubes could cause harm to the vocal cords, or trachea. This can lead to grave injuries or even death.

The company has since recalled 629 devices from the US that were distributed between 1 April 2016 - 1 January 2022.

Avanos Medical feeding tube The company recall communication stated that 60 patients were injured and 23 died due to the wrong placement of nasogastric tubes when making use of Cortrak* 2 EAS.

Avanos Medical feeding tube Avanos Medical feeding tube Avanos Medical will revise the labelling after the recall. This will include updated instructions on how to use the device and the intended use of Cortrak*2 EAS.

The revised guidelines require users to verify the location of tubes in accordance with protocols from their respective institutions before making use of them.

Cortrak 2 eternal access system Avanos Medical has its headquarters in Alpharetta Georgia. The company has more than 90 markets that are branded with its brands.

Last December, the business reached an agreement to purchase OrthogenRx with a $160m deal. Avanos Medical Avanos Medical successfully closed the acquisition of OrthogenRx in January.


My Website: https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/                      
     
 
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