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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 due to tube misplacements.

The US Food and Drug Administration has classified Avanos Medical’s Cortrak*2 Enteral Access System (EAS), as a Class 1 recall.

A Class I recall is considered the most serious out of the three classes.

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

Avanos Medical feeding tube This device can be used to assist health care professionals in placing medical feeding tubes into patients. It also provides real-time information regarding tube placement.

But, the incorrect placement of nasogastric and nasoenteric tubes can damage the vocal cords of a patient or trachea, lungs, or vocal cords which can cause serious injuries or even death.

The company recalls 629 devices sold throughout the US between January 2016 and January 2022.

The company also stated in a recall announcement that there were more than 23 patients and 60 injuries who died since 2015 due to the incorrect placement of nasogastric feed tubes in the Cortrak* 2 EAS.

Avanos Medical Avanos Medical will revise the labelling in the wake of the recall. This will include updated instructions for use and intended usages of Cortrak*2 EAS.

The updated guidelines instruct users to ensure that the tube is set up according to the protocol of their institution prior to use.

Avanos Medical is based in Alpharetta (Georgia), USA. Avanos Medical feeding tube It specializes in the manufacturing of medical equipment. Avanos Medical markets its well-known brands in more than 90 countries.

Avanos Medical feeding tube Cortrak 2 eternal access system Last December, the company reached an agreement to purchase OrthogenRx with the amount of $160 million. https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.


My Website: https://www.medicalbuyer.co.in/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/
     
 
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