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

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

Avanos Mediacal Cortrak 2 The US Food and Drug Administration (FDA) has identified the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS) as a class I recall.

A Class I recall is considered to be the most important of all three classes.

Avanos Medical recalls Cortrak*2 EAS after reports of injury and deaths due to misplacements of nasogastric or nasoenteric tubes.

The device is designed to help medical professionals who are trained to place medical tubes for feeding in patients and offer the most current information about tube placement.

But, the incorrect positioning of the nasogastric or nasoenteric, tubes can cause severe injury or death.

https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html The company recalls 629 devices, which were made available across the US between 1 April 2016 to 1 January 2022.

The company also said 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 will revise the labelling after the recall. This includes updating the instructions for use and intended uses of Cortrak* 2 EAS.

Users should also verify that tubes have been installed in accordance with the protocols of the institution prior to use.

Avanos Medical has its headquarters in Alpharetta Georgia. It sells its brands in over 90 different countries.

Avanos Medical feeding tube The company signed a $160 million agreement in December of last year to acquire OrthogenRx. Cortrak 2 eternal access system Avanos Medical closed on the acquisition in January.

Cortrak 2 eternal access system
Read More: https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html
     
 
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