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FDA classifies Avanos Medical’s Cortrak*2 EAS recall as Class I

Avanos Medical recalled Cortrak* 2 EAS in the wake of reports of injuries and deaths caused by tube malfunctions.

The US Food and Drug Administration has identified Avanos Medical’s Cortrak*2 enteral access system (EAS) to be recalled as Class II recall.

A Class I can remember is considered to be the most serious out of all three classes.

Avanos Medical recalled Cortrak* 2 EAS in the wake of incidents of injury and deaths caused by nasoenteric and Nasogastric tube malfunctions.

Avanos Mediacal Cortrak 2 The device is intended to aid trained health care personnel place medical tubes for feeding within patients, and provide live information about the tube's location in real-time. placement.

But, the incorrect placement of the nasogastric/nasoenteric tubs cause serious injuries or even death.

Overall, the company has been able to recall 629 devices distributed in the US between April 1st, 2016 and 1 January 2022.

feeding tube placement According to the recall notice the company has stated that since 2015 there have been 60 injuries and 23 deaths resulting from the improper placement or misuse of the Nasogastric feeding tubes when using the Cortrak* 2 EAS.

Avanos Medical Avanos Medical will revise the labelling following the recall. This includes changing the instructions as well as the intended uses for Cortrak* 2 EAS.

Cortrak 2 eternal access system Cortrak 2 eternal access system These revised guidelines direct users to verify tube placement according to the institution's protocols prior to use.

Avanos Medical is based in Alpharetta (Georgia) in the United States. Avanos Medical feeding tube It specializes in the production of medical devices. The company markets its recognised brands across over 90 countries.

Avanos Medical feeding tube The company agreed to buy OrthogenRx at $160 million during December. Avanos Medical closed the acquisition on the 20th of January.


Homepage: https://aacnjournals.org/ajcconline/article/29/1/22/30624/Pneumothoraces-Prevented-With-Use-of
     
 
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