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FDA has identified Avanos's Cortrak*2 EAS recall Class I

Avanos Medical pulled Cortrak*2 EAS from service after receiving reports of deaths and injuries 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 an I Class recall.

Avanos Medical A Class 1 recall is the most serious of three classes.

Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths caused by misplacements of nasogastric tubes.

Avanos Medical feeding tube The device is designed to aid health care professionals place medical feeding tubes onto patients.

A wrong placement of the Nasogastric tube and nasoenteric tube could cause serious injury or even death.

The company is recalling 629 devices, which were sold across the US from 1 April 2016 to 1 January 2022.

Avanos Medical feeding tube The communication regarding the recall from the company added that there have been more than 23 patient deaths since 2015 due to the misplacement or misplacement nasogastric feeding tubes while using the Cortrak* 2 EAS.

Avanos Medical will revise the labelling after the recall. Avanos Medical feeding tube This will include updating instructions regarding the use and intended uses of the Cortrak*2 EAS.

Users are also directed to confirm that the tubes have been placed according to protocols of the institution prior to make use of them.

feeding tube placement Avanos Medical has its headquarters in Alpharetta Georgia. The company sells its recognized brands in over 90 countries.

The company signed an agreement to purchase OrthogenRx at $160 million during December. Avanos Medical concluded the acquisition on the 20th of January.


Read More: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm
     
 
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