Notes

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

Avanos Medical pulled Cortrak*2 EAS off service following reports about injuries and deaths due to tube missing.

The US Food and Drug Administration has identified Avanos Medical’s Cortrak*2 enteral access system (EAS) to be recalled as Class II recall.

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

Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and deaths caused by nasoenteric and nasogastric tube misplacements.

The device was created to aid trained health care professionals when placing medical feed tubes into patients.

A wrong placement of the Nasogastric tube and nasoenteric tube could result in serious injuries or death.

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

According to the company's recall notice the company's recall communication, there were 53 deaths and 60 injuries during 2015 because of the misplacement of nasogastric tube feeding tubes during use of the Cortrak* 2 EAS.

Avanos Medical, following the recall, will update the device’s labelling. This will include an update of the instructions and the planned uses for Cortrak* 2 EAS.

The updated guidelines require users to confirm the placement of tubes based on protocols from their respective institutions before using them.

Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on manufacturing clinical medical devices. Avanos Medical has over 90 markets that are branded with its brands.

The company signed a $160m agreement in December of last year to acquire OrthogenRx. Cortrak 2 eternal access system feeding tube placement Avanos Medical concluded the acquisition on January 20th.

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