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

Avanos Medical pulled Cortrak*2 EAS off service following reports of deaths and injuries related to tube displacements.

The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak*2 Enteral Access System (EAS) as an I Class recall.

https://www.cyberera.com.ng/2022/05/17/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ A Class I recall refers to the most difficult of three classes.

Avanos Medical recalls Cortrak*2 EAS following reports of injuries and death due to the wrong placement of nasogastric and nasoenteric tubes.

https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Avanos Medical The device allows trained healthcare professionals to insert medical feeding tubes in patients.

A wrong placement of the Nasogastric or nasoenteric tubes can cause serious injury or even death.

https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/ The company has since been able to recall 629 devices in the US that were sold between 1 April 2016 - 1 January 2022.

https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system The communication regarding the recall from the company stated that there were 60 injuries and 23 patient deaths since 2015 due to the misplacement of the nasogastric feeding tubes when using the Cortrak* 2 EAS.

Avanos Medical feeding tube Avanos Medical, following the recall, will be updating the device’s labelling. This will include changing the instructions as well as the intended uses for Cortrak* 2 EAS.

Cortrak 2 eternal access system The updated guidelines require users to verify the location of tubes according to protocols of their institutions prior to making use of them.

Avanos Medical has its headquarters in Alpharetta Georgia. The company operates in more than 90 markets that are branded with its brands.

Avanos Mediacal Cortrak 2 In December of last year the company signed an agreement worth $160 million to acquire OrthogenRx. Avanos Medical concluded the acquisition on January 20th.


My Website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/
     
 
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