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Avanos Medical has recalled Cortrak*2 EAS in response to reports of deaths and injuries due to tube malfunctions.
The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak*2 Enteral Access System (EAS) as an I Class recall.
Cortrak 2 eternal access system A Class I recall is a reference to the most severe of the three classes.
Avanos Medical pulled Cortrak* 2 EAS out of service due to death and injuries of patients due to nasogastric tubes misplacements.
This device can be used to assist health care professionals in placing medically-approved feeding tubes for patients. It also gives real-time information regarding tube placement.
However, the wrong positioning of nasogastric or nasal tubes could damage the vocal cords of patients and trachea or lungs which can cause serious injuries or death.
Avanos Medical Avanos Medical feeding tube The company has removed 629 devices from the US that were distributed between April 1, 2016 and 1 January 2022.
According to the recall communication the company has stated that in the year 2015, there have been more than 60 injuries and 23 deaths resulting from the incorrect placement or misuse of the nasogastric feeding tube while using the Cortrak* 2 EAS.
In the wake of the recall, Avanos Medical will update the labeling of the device. Avanos Medical This includes changing the instructions for Cortrak*2 EAS as well as its the intended use.
The updated guidelines also instruct users to verify the placement of their tubes according to the institution's protocols before usage.
Avanos Medical has its headquarters in Alpharetta Georgia. It sells its brands in over 90 different countries.
In December of last year Avanos Medical entered into an agreement worth $160 million to purchase OrthogenRx. Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.
Cortrak 2 eternal access system
Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
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