Notes

FDA classifies Avanos Medical's Cortrak*2 EAS recall as Class I

Avanos Medical recalls Cortrak*2 EAS in the wake of reports of injury and death due to tube misplacements.

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

A Class I recall is considered the most serious out of the three classes.

Avanos Medical called off Cortrak* 2, EAS due to deaths and injuries resulting from the misplacement of nasogastric tubs.

The device is intended to aid trained health care personnel place medical tube feedings in patients and offer the most current information about tube placement.

Avanos Medical feeding tube But, the incorrect placement of the nasogastric/nasoenteric tubs cause serious injuries or even death.

The company has been able to recall 629 devices in the US that were distributed between 1 April 2016 - 1 January 2022.

According to the recall announcement issued by the company it was reported that there were 53 deaths and 60 injuries during 2015 because of the misplacement of nasogastric tube feeding tubes when using the Cortrak* 2 EAS.

After the recall, Avanos Medical will update the labeling of the device. Avanos Medical feeding tube This will include changing the instructions for Cortrak*2 EAS as well as its the intended use.

The revised guidelines advise users to ensure that the tube is placed according to the protocols of the institution before usage.

Avanos Medical, based in Alpharetta Georgia America, is a manufacturer of clinical medical devices. Its brands are available in over 90 countries.

The company signed an agreement with OrthogenRx to acquire the company in a $160 million deal. Cortrak 2 eternal access system Avanos Medical concluded the acquisition on the 20th of January.


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