Notes

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

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

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 kind out of three classes.

https://farangmart.co.th/author/avanos-mediacal-cortrak-2kify494/ Avanos Medical called off Cortrak* 2, EAS, due to deaths and injuries resulting from the misplacement of tubs for nasogastric surgery.

The device was designed to assist trained health care workers in placing medical feed tubes for patients.

Avanos Medical A wrong placement of the Nasogastric tube and nasoenteric tube could result in serious injuries or death.

feeding tube placement Overall, the company recalls 629 devices distributed across the US between 1 April 2016 and 1 January 2022.

The company also noted in a recall announcement that there were sixty injuries and 23 people that died in 2015 as a result of the incorrect placement of nasogastric feed tubes when using the Cortrak* 2 EAS.

Avanos Medical will make the needed changes to the labelling of the device following the recall. http://sc.sie.gov.hk/TuniS/penzu.com/p/19710fbb This will include updated instructions for use and intended usages of Cortrak*2 EAS.

The updated guidelines instruct users to ensure that the tube is installed in accordance with the guidelines of their institution prior usage.

The headquarters are located in Alpharetta, Georgia, US, Avanos Medical focuses on manufacturing clinical medical devices. The company markets its recognised brands in more than 90 countries.

In December, the company entered into a $160 million deal to acquire OrthogenRx. Avanos Medical concluded the acquisition on January 20th.

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