Notes

FDA has identified Avanos Medical’s Cortrak*2 EAS recall Class I

Avanos Medical called off Cortrak* 2 EAS in response to patient death and injuries caused by tube malfunctions.

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

The Class 1 recall is the most severe of the three classes.

Avanos Medical pulled Cortrak* 2 EAS from service after patient deaths and injuries due to misplacements of nasogastric tubes.

The device is able to assist health care professionals in placing medical feeding tubes into patients. It also provides real-time details about the placement of tubes.

A wrong placement of the Nasogastric tube and nasoenteric tube could cause serious injury , or even the death of a patient.

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

According to the company's recall notice it was reported that there were 60 injuries and 23 deaths in 2015 due the incorrect placement of nasogastric feeding tubes when using the Cortrak* 2 EAS.

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

The revised guidelines also direct users to confirm tube placement according to the institution's protocol prior to use.

Avanos Medical Avanos Medical, based in Alpharetta Georgia in the United States is a producer of clinical medical devices. Avanos Mediacal Cortrak 2 The company sells its recognized brands across more than 90 countries.

In December Avanos Medical entered into a $160 million deal to purchase OrthogenRx. Avanos Medical Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.


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