Notes

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

Avanos Medical called off Cortrak* 2 EAS in response to the patient death and injuries caused by tube misplacements.

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

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

Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths due to misplacements of the nasogastric tube.

The device allows skilled healthcare personnel to place medical feeding tubes in patients.

However, the wrong placement of the nasogastric or nasoenteric tubes could cause severe injury or death.

Avanos Medical In total, the company has recalls 629 devices sold in the US between April 1st, 2016 to 1 January 2022.

The communication regarding the recall from the company also stated that there had been sixty injuries and 23 deaths of patients since the year 2015 due to misplacement of nasogastric feeding tubes while using the Cortrak* 2 EAS.

Avanos Medical is updating the labelling on the device after the recall. This will include updating the instructions regarding the use and intended usage of Cortrak* 2 EAS.

The revised guidelines require users to confirm the location of tubes in accordance with protocols of their institutions prior to making use of the tubes.

Avanos Medical's headquarters are located in Alpharetta Georgia America. They specialize in manufacturing medical equipment. The company sells its recognized brands across over 90 countries.

The company reached an agreement with OrthogenRx to acquire the company for $160 million in a transaction. Avanos Medical feeding tube Avanos Medical closed on the acquisition in January.

Avanos Mediacal Cortrak 2 Avanos Medical
Website: https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/