Notes

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 related to tube displacements.

The US Food and Drug Administration has classified Avanos Medical's Cortrak*2 Entral Access System (EAS), as a Class 1 recall.

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

Avanos Medical called off Cortrak*2, EAS, following injuries and deaths resulting from misplacements of nasogastric tubs.

The device allows skilled healthcare professionals to insert medically-approved feeding tubes into patients.

But, the incorrect placement of nasogastric or nasoenteric tubes could cause damage to the vocal cords of a patient, lungs or trachea which can cause serious injuries or even death.

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

Cortrak 2 eternal access system According to the company's recall notice it was reported that there were sixty injuries and 23 deaths in 2015 due the incorrect placement of nasogastric feeding tubes during use of the Cortrak* 2 EAS.

Avanos Medical will revise the labelling in the wake of the recall. Avanos Medical This will include the updating of Cortrak*2 EAS's instructions as well as intended uses.

These revised guidelines direct users to ensure that the tube is placed as per the guidelines of the institution's prior use.

Avanos Medical is based in Alpharetta (Georgia) in the United States. It is a specialist in manufacturing medical devices. Avanos Medical feeding tube Avanos Medical feeding tube Avanos Medical markets its well-known brands across over 90 countries.

Last December, the business entered into an agreement to buy OrthogenRx with a $160m deal. Avanos Medical feeding tube Avanos Medical completed the acquisition on the 20th of January.


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