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FDA HAS IDENTIFIED AVANOS MEDICAL’S CORTRAK*2 EAS RECALL AS CLASS I

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Avanos Medical recalls Cortrak*2 EAS following reports of injuries and deaths
due to tube misplacements.

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

A Class I remember is the most serious one out of three classes.

Avanos Medical recalls Cortrak*2 EAS following reports of injuries and death due
to misplacements of nasogastric or nasoenteric tubes.

The device allows trained healthcare professionals to insert medical feeding
tubes inside patients.

But, incorrect positioning of nasogastric/nasoenteric tubes can result in severe
injuries or even death.

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

Avanos Medical In the recall announcement the company said that since 2015 there
have been 60 injuries and 23 deaths due to the improper placement or use of
Nasogastric feeding tubes when making use of the Cortrak* 2 EAS.

https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical
In the wake of the recall, Avanos Medical will update the labeling of the
device.
https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/
This will include changing the instructions for Cortrak*2 EAS as well as its
intended uses.

The updated guidelines instruct users to verify that the tube has been installed
in accordance with the guidelines of the institution before usage.

Avanos Medical is based in Alpharetta (Georgia), USA. Cortrak 2 eternal access
system Cortrak 2 eternal access system It specializes in the production of
medical devices. Avanos Medical markets its well-known brands in more than 90
countries.

https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf
Avanos Medical Cortrak 2 eternal access system In December of last year, the
company entered into an agreement worth $160 million to acquire OrthogenRx.
Avanos Medical closed on the acquisition in January.

Avanos Medical


Public Last updated: 2022-11-09 10:05:28 AM

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