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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 incidents of injury and deaths caused by tube missing.

http://ezproxy.cityu.edu.hk/login?url=https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview https://autohub.ng/user/profile/1827672 The US Food and Drug Administration has classified Avanos Medical's Cortrak*2 enteral Access System (EAS), as a Class 1 recall.

Avanos Mediacal Cortrak 2 The Class 1 recall is the most severe of three classes.

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

Cortrak 2 eternal access system The device is designed to aid health care professionals put medical feed tubes on patients.

The wrong placement of Nasogastric or nasoenteric tubes can cause serious injury , or even the death of a patient.

The company has now recalled 629 devices from the US that were distributed between April 1, 2016 and 1 January 2022.

The company recall communication stated that 60 patients suffered injuries and 23 were killed due to the wrong placement of nasogastric tubes when using Cortrak* 2 EAS.

Avanos Medical will make the necessary changes to the labeling of the device in the wake of the recall. Avanos Medical feeding tube This will include changing the instructions for Cortrak*2 EAS as well as its intended uses.

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

Avanos Medical is based in Alpharetta (Georgia), USA. feeding tube placement It specializes in manufacturing medical devices. Avanos Medical Its brands are available in more than 90 countries.

In December of last year, the company entered into an agreement to buy OrthogenRx with the amount of $160 million. Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.


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