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FDA classifies Avanos Medical's Cortrak*2 EAS recall as Class 1

Avanos Medical recalled Cortrak* 2 EAS in the wake of incidents of injury and patient deaths due to tube malfunctions.

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

https://classifieds.lt/index.php?page=user&action=pub_profile&id=3143243 The term "Class I Recall" refers to the most severe of the three classes.

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

The device is able to assist healthcare professionals to insert medically-approved feeding tubes for patients. It also provides real-time information about tube placement.

But, incorrect placement of nasogastric/nasoenteric tubs can cause severe injuries, or even death.

Cortrak 2 eternal access system In total, the company has recalls 629 devices distributed across the US between April 1st, 2016 to 1 January 2022.

Avanos Medical feeding tube In the recall announcement the company has stated that in the year 2015, there have been 60 injuries as well as 23 deaths due to the improper placement or the use of a Nasogastric feeding tubes when using the Cortrak* 2 EAS.

Avanos Medical, following the recall, will be updating the device’s labelling. This will include an update of the instructions on use and intended use of Cortrak* 2 EAS.

Users should also verify that tubes have been put in the correct manner according to the guidelines of the institution before they make use of them.

Cortrak 2 eternal access system Avanos Medical has its headquarters in Alpharetta Georgia. Avanos Medical The company has more than 90 markets that are branded with its brands.

The company signed an agreement with OrthogenRx to purchase the company for $160 million in a transaction. Avanos Medical closed the acquisition on 20 January.

Cortrak 2 eternal access system
My Website: https://www.transtats.bts.gov/exit.asp?url=https://www.simmonsandfletcher.com/blog/injuries-incorrect-feeding-tube-placement/
     
 
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