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FDA announces the Cortrak*2 of Avanos Medical's EAS Recall Class I

Avanos Medical recalled Cortrak* 2 EAS after reports of injuries and patient deaths caused by tube malfunctions.

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

A Class I remember is considered to be to be the most important of the three classes.

Avanos Medical recalled Cortrak* 2 EAS in the wake of reports of injuries and deaths caused by nasoenteric and Nasogastric tube misplacements.

https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm The device is intended to aid health care professionals put medical feed tubes on patients.

Avanos Mediacal Cortrak 2 Cortrak 2 eternal access system 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 injury or even death.

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

According to the recall announcement issued by the company, there were sixty injuries and 23 deaths during 2015 because of the incorrect placement of nasogastric feeding tubes in the course of using the Cortrak* 2 EAS.

Avanos Medical feeding tube Avanos Medical will make the needed changes to the labeling of the device following the recall. Avanos Medical This will include updated instructions for use and intended usages of the Cortrak*2 EAS.

Avanos Medical feeding tube The updated guidelines instruct users to confirm that the tube was placed according to the protocols of their institution prior to use.

Avanos Medical has its headquarters in Alpharetta Georgia. It sells its brands in over 90 different countries.

Last December, the business reached an agreement to purchase OrthogenRx with an agreement worth $160 million. Avanos Medical closed on the acquisition in January.


Read More: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause