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

Avanos Medical recalls Cortrak*2 EAS after reports of injury and deaths due to tube incorrect placement.

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

A Class I Recall is the most serious type of the three classes.

Avanos Medical has recalled Cortrak*2 EAS following reports of injuries or deaths due to misplacements of the nasogastric tube.

The device was developed to assist health care professionals when placing medical feed tubes into patients.

https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ But, the incorrect placement of nasogastric and nasoenteric tubes could cause damage to the vocal cords of a patient or trachea, lungs, or vocal cords and cause severe injury or even death.

Avanos Mediacal Cortrak 2 Overall, the company recalled 629 devices that were sold across the US between 1 April 2016 and 1 January 2022.

feeding tube placement The communication regarding the recall from the company added that there had been 60 injuries and 23 deaths in patients since 2015 due to misplacement of Nasogastric feeding tubes that were used with the Cortrak* 2 EAS.

In the wake of the recall Avanos Medical will update the device's labelling. This will include updating the instructions for use and intended uses of Cortrak* 2 EAS.

The new guidelines direct users to confirm that the tube was set up according to the protocol of their institution prior usage.

Cortrak 2 eternal access system Avanos Medical, based in Alpharetta Georgia America, is a manufacturer of medical devices that are clinically proven. Cortrak 2 eternal access system The company markets its recognised brands across more than 90 countries.

Cortrak 2 eternal access system Avanos Medical In December of last year Avanos Medical entered into a $160 million deal to purchase OrthogenRx. Cortrak 2 eternal access system Avanos Medical closed the acquisition on 20 January.


Here's my website: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/
     
 
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