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

Avanos Medical has recalled Cortrak*2 EAS in response to reports of deaths and injuries caused by 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.

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

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

Avanos Medical feeding tube Avanos Medical feeding tube This device can be used to assist trained health care professionals in placing medical feeding tubes in patients. It also provides in real-time information regarding tube placement.

However, the wrong placement of the nasogastric, or nasoenteric tube could cause serious injury or even death.

The company has recalled 629 devices in the US between January 2016 to January 2022.

Avanos Mediacal Cortrak 2 According to the recall notice the company said that in the year 2015, there have been 60 injuries as well as 23 deaths resulting from the misplacement or misuse of the Nasogastric feeding tubes when making use of the Cortrak* 2 EAS.

Avanos Medical is updating the labels on the device following the recall. This includes updating the instructions on how to use the device as and the intended uses for Cortrak*2 EAS.

These revised guidelines direct users to verify tube placement according to the institution's protocols prior use.

https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ Avanos Medical, based in Alpharetta Georgia, USA is a producer of medical devices for clinical use. It sells its brands in over 90 different countries.

The company came to an agreement with OrthogenRx to purchase the company in a $160m deal. https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ Avanos Medical closed on the acquisition in January.


Homepage: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/
     
 
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