Notes

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

Avanos Medical recalled Cortrak* 2 EAS following incidents of injury and deaths caused by tube missing.

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

The most dangerous of the three kinds is a Class I remember.

Avanos Medical recalled Cortrak* 2 EAS following reports of injuries and deaths due to nasoenteric or Nasogastric tube malfunctions.

Cortrak 2 eternal access system The device allows healthcare personnel to place medically-approved feeding tubes into patients.

However, the wrong placement of the nasogastric, or nasoenteric tubes could result in severe injuries or even death.

Overall, the company recalled 629 devices that were sold in the US between April 1st, 2016 to 1 January 2022.

According to the recall notice the company has stated that as of 2015, there had been 60 injuries and 23 deaths as a result of the incorrect placement or misuse of the nasogastric feeding tube while making use of the Cortrak* 2 EAS.

Avanos Medical will make the necessary changes to the labeling of the device in the wake of the recall. Avanos Medical feeding tube Avanos Medical feeding tube This will include updating the instructions on how to use the device and the intended use of Cortrak*2 EAS.

Avanos Medical The revised guidelines require users to verify the placement of tubes based on protocols of their institutions before making use of the tubes.

Avanos Medical, based in Alpharetta Georgia America is a producer of medical devices that are clinically proven. The company markets its recognised brands across more than 90 countries.

Avanos Medical The company entered into a $160m agreement last December to acquire OrthogenRx. Avanos Medical successfully closed the acquisition of OrthogenRx on the 20th of January.


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