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Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and patient deaths 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.
Avanos Medical A Class I remember is considered to be the most serious of the three classes.
Avanos Medical Avanos Medical called off Cortrak*2, EAS, following injuries and deaths resulting from the misplacement of tubs for nasogastric surgery.
Cortrak 2 eternal access system This device can be used to aid trained healthcare professionals to insert medically-approved feeding tubes for patients. Avanos Medical It also provides in real-time information regarding tube placement.
Incorrect placement of Nasogastric tube and nasoenteric tube could result in serious injuries or death.
Overall, the company has been able to recall 629 devices distributed in the US between 1 April 2016 to 1 January 2022.
The notice of recall issued by the company stated that there have been 60 injuries and 23 deaths of patients since the year 2015 due to misplacement of nasogastric feeding tubes while using the Cortrak* 2 EAS.
Avanos Medical will make the necessary changes to the labeling of the device following the recall. Avanos Medical feeding tube This includes changing the instructions for Cortrak*2 EAS as well as its the intended use.
The updated guidelines instruct users to confirm that the tube is installed in accordance with the guidelines of their institution prior to use.
Avanos Medical is based in Alpharetta (Georgia), USA. It is a specialist in the production of medical devices. The company operates in more than 90 markets to sell its renowned brands.
Cortrak 2 eternal access system The company came to an agreement with OrthogenRx to acquire the company in a $160m transaction. Avanos Medical completed the acquisition on the 20th of January.
Website: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/
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