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

Avanos Medical has recalled Cortrak*2 EAS because of reports of injuries and deaths from tube malfunctions.

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

A Class I remember is the most serious kind of the three classes.

Avanos Medical called off Cortrak* 2, EAS, following injuries and deaths resulting from the misplacement of tubs for nasogastric surgery.

The device was created to assist health care professionals when placing medical feed tubes into patients.

But, improperly placed nasogastric/nasoenteric tubes could cause harm to the vocal cords or trachea. This could lead to serious injuries or even death.

The company has recalled 629 devices throughout the US between January 2016 and January 2022.

https://penzu.com/p/26a6d9ec The recall communication from the company added that there were sixty injuries and 23 patient deaths since 2015 due to the misplacement or misplacement Nasogastric feeding tubes that were used with the Cortrak* 2 EAS.

Avanos Medical is updating the labelling on the device after the recall. This includes an update of the instructions and the planned uses for Cortrak* 2 EAS.

Revisioned guidelines require users to verify the placement of tubes according to protocols of their institutions before making use of them.

https://canvas.instructure.com/eportfolios/1616623/Home/Avanos_Medical_is_facing_a_Class_I_recall_due_to_feeding_tube_system_malfunctions_that_have_caused_23_deaths_since_2015_ The headquarters of Avanos Medical is in Alpharetta Georgia USA. Avanos Medical feeding tube placement They focus on the manufacturing of medical devices. Avanos Medical's well-known brands are available in more than 90 countries.

Avanos Medical Last December Avanos Medical entered into an agreement of $160 million to acquire OrthogenRx. Avanos Medical closed on the acquisition in January.


My Website: https://coderwall.com/p/xjvobw/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm-ece925b8-8709-4804-8a27-1979a80d5ee6
     
 
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