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FDA classifies Avanos Medical's Cortrak*2 EAS recall as Class 1

Avanos Medical recalled Cortrak* 2 EAS in the wake of incidents of injury and deaths due to tube missing.

The US Food and Drug Administration has classified Avanos Medical’s Cortrak*2 Enteral Access System (EAS), as a Class 1 recall.

Cortrak 2 eternal access system Avanos Mediacal Cortrak 2 A Class I remember is the most serious one out of three classes.

Avanos Mediacal Cortrak 2 Avanos Medical recalled Cortrak* 2 EAS after reports of injuries and deaths due to nasoenteric nasogastric tube misplacements.

Avanos Medical feeding tube The device is intended to help trained health care personnel place medical feeding tubes in patients and offer the most current information about tube placement.

feeding tube placement feeding tube placement But, incorrect placement of nasogastric/nasoenteric tubs can cause serious injuries or even death.

The company has recalled 629 devices distributed throughout the US between January 2016 to January 2022.

Avanos Medical feeding tube The notice of recall issued by the company also stated that there were sixty injuries and 23 patient deaths since 2015 due to misplacement of Nasogastric feeding tubes that were used with the Cortrak* 2 EAS.

Avanos Medical will revise the labelling in the wake of the recall. This includes an update of the instructions on use and intended use of Cortrak* 2 EAS.

Cortrak 2 eternal access system The revised guidelines require that users confirm the position of tubes based on protocols from their respective institutions before using the tubes.

Avanos Medical, based in Alpharetta Georgia, USA is a maker of clinical medical devices. The company markets its recognised brands across more than 90 countries.

The company agreed to buy OrthogenRx for $160 million in December. Avanos Medical closed the acquisition on the 20th of January.


Here's my website: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
     
 
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