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FDA confirms the Avanos Medical Cortrak*2 EAS recall as Class I

Avanos Medical recalls Cortrak*2 EAS in the wake of reports of injury and deaths due to tube incorrect placement.

Avanos Medical 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 three classes.

Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths caused by misplacements of nasogastric tubes.

Cortrak 2 eternal access system The device is able to assist healthcare professionals to insert medical feeding tubes in patients. It also gives real-time information regarding tube placement.

Avanos Medical feeding tube However, the incorrect placement of the nasogastric, or nasoenteric, tubes can cause serious injury or even death.

The company has recall 629 devicesthat were made available in the US between 1 April 2016 until 1 January 2022.

Avanos Medical feeding tube According to the company's recall communication it was reported that 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 will make the needed changes to the labelling of the device following the recall. This includes changing the instructions for Cortrak*2 EAS as well as its expected uses.

Users should also verify that tubes have been placed according to protocols of the institution before they utilize them.

Avanos Medical is based in Alpharetta (Georgia), USA. Avanos Medical feeding tube Its focus is on manufacturing medical equipment. Avanos Medical feeding tube The company's recognized brands are available in over 90 countries.

The company came to an agreement with OrthogenRx to purchase the company for $160 million in a transaction. Avanos Medical completed the acquisition on the 20th of January.


Read More: https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/