Notes

FDA declares Avanos Medical’s Cortrak*2 EAS Recall Class I

Avanos Medical recalled Cortrak* 2 EAS in the wake of reports of injuries and patient deaths due to tube malfunctions.

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 recall is considered to be the most important of all three classes.

Avanos Medical called off Cortrak*2, EAS, after deaths and injuries that resulted from the misplacement of nasogastric tubs.

This device can be used to assist health professionals with the placement of medical feeding tubes into patients. It also gives real-time information regarding tube placement.

However, the wrong positioning of nasogastric or nasal tubes can damage the vocal cords of a patient or trachea, lungs, or vocal cords which can cause serious injuries or even death.

In total, the company has been able to recall 629 devices sold in the US between 1 April 2016 to 1 January 2022.

The recall notification from the company said that 60 patients suffered injuries and 23 of them died as a result of the wrong placement of nasogastric tubes when using Cortrak* 2 EAS.

Avanos Medical is updating the marking on the device following the recall. This includes updating the instructions on how to use the device as well as the intended use of Cortrak*2 EAS.

Avanos Medical feeding tube The updated guidelines instruct users to verify tube placement as per the guidelines of the institution's prior to use.

Avanos Medical Avanos Medical, based in Alpharetta Georgia, USA is a maker of clinical medical devices. Cortrak 2 eternal access system Cortrak 2 eternal access system Its brands are available in over 90 countries.

In December Avanos Medical entered into an agreement of $160 million to acquire OrthogenRx. Avanos Medical Avanos Medical completed the acquisition on January 20.


My Website: https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas