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FDA classifies Avanos Medical's Cortrak*2 EAS recall as Class I

Avanos Medical pulled Cortrak*2 EAS from service after receiving reports about injuries and deaths due to tube misplacements.

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

Avanos Medical feeding tube A Class I can remember is considered to be to be the most important of the three classes.

Avanos Medical recalled Cortrak* 2 EAS in the wake of incidents of injury and deaths caused by nasoenteric and nasogastric tube misplacements.

The device allows skilled healthcare professionals to insert medically-approved feeding tubes into patients.

The wrong placement of nasogastric and nasoenteric tube can cause serious injury , or even death.

The company has recalled 629 devices in the US between January 2016 to January 2022.

https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system According to the recall notice the company said that as of 2015, there had been more than 60 injuries and 23 deaths resulting from the improper placement or the use of a Nasogastric feeding tubes while making use of the Cortrak* 2 EAS.

Cortrak 2 eternal access system Avanos Medical will make the necessary updates to the labelling of the device in the wake of the recall. This will include updating the instructions for use and intended usages of Cortrak*2 EAS.

These updated guidelines require users to verify tube placement in accordance with the protocol of the institution's prior to use.

Avanos Medical feeding tube Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on making medical devices for clinical use. The brand's name is accessible in over 90 countries.

feeding tube placement The company signed a $160m contract in December last year to purchase OrthogenRx. Avanos Medical completed the acquisition on January 20.


Here's my website: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system
     
 
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