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

Avanos Medical called off Cortrak* 2 EAS in response to the patient injury and deaths caused by tube misplacements.

The US Food and Drug Administration (FDA) has designated the recall issued by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as a class I recall.

https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ The term "Class I Recall" is a reference to the most severe of three classes.

Avanos Medical recalls Cortrak*2 EAS after reports of injury and death due to incorrect placements of nasogastric or nasal tubes.

Cortrak 2 eternal access system The device is intended to assist health professionals put medical feed tubes on patients.

Incorrect placement of Nasogastric tube and nasoenteric tube could cause serious injury , or even death.

The recall affects 629 devices that were available in the US between 1 February 2016 to 1 January 2022.

According to the company's recall notice the company's recall communication, there were 60 injuries and 23 deaths in 2015 as a result of the incorrect placement of nasogastric feeding tubes during use of the Cortrak* 2 EAS.

Avanos Medical feeding tube After the recall Avanos Medical will update the labeling of the device. This will include changing the instruction on use and intended use of Cortrak* 2 EAS.

Users are also advised to ensure that the tubes are put in the correct manner according to the guidelines of the institution prior to make use of them.

Avanos Mediacal Cortrak 2 The headquarters of Avanos Medical is in Alpharetta Georgia America. They focus on the manufacturing of medical equipment. Avanos Mediacal Cortrak 2 Avanos Medical markets its well-known brands across over 90 countries.

The company agreed to acquire OrthogenRx for $160 million in December. Avanos Medical concluded the acquisition on January 20th.

Avanos Medical
Website: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding
     
 
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