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

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

The US Food and Drug Administration has acknowledged the Cortrak*2 of Avanos Medical's Enal Access System Recall (EAS) in a Class I recall.

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

Avanos Medical recalled Cortrak* 2 EAS in the wake of incidents of injury and patient deaths due to nasoenteric nasogastric tube misplacements.

Cortrak 2 eternal access system The device allows trained healthcare professionals to insert medically-approved feeding tubes into patients.

But, the incorrect placement of the nasogastric/nasoenteric tubs cause severe injuries, or even death.

Avanos Medical feeding tube Avanos Medical feeding tube The recall covers 629 devices that were available in the US between February 1st, 2016 until 1 January 2022.

The company also said in a recall communication that there were 60 injuries and 23 patients killed since 2015 because of the feed tubes that were not properly placed that were connected to the Cortrak* 2 EAS.

Avanos Medical will make the necessary changes to the labeling of the device following the recall. This includes updating the instructions regarding the use and intended usage of Cortrak* 2 EAS.

Avanos Medical The updated guidelines require users to verify the location of tubes according to protocols of their institutions prior to making use of them.

The headquarters are located in Alpharetta, Georgia, US, Avanos Medical focuses on making medical devices for clinical use. The company sells its brands across more than 90 countries.

Avanos Medical Avanos Mediacal Cortrak 2 Avanos Medical feeding tube Last December, the company entered into a $160 million deal to acquire OrthogenRx. Avanos Medical feeding tube Avanos Medical concluded the acquisition on January 20th.


Read More: https://www.supplychain.nhs.uk/icn/avanos-medical-uk-ltd-factory-closure-on-entral-branded-products/