Notes

FDA has declared Avanos Medical's Cortrak*2 EAS Recall Class I

Avanos Medical called off Cortrak* 2 EAS in response to the patient injury and deaths caused by tube malfunctions.

feeding tube placement The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak* 2 Enteral Access System (EAS) as an I Class recall.

The term "Class I Recall" is a reference to the most severe of the three classes.

Avanos Medical called off Cortrak*2, EAS, following injuries and deaths resulting from the misplacement of tubs for nasogastric surgery.

The device was created to aid trained health professionals in putting medical feed tubes in patients.

Avanos Mediacal Cortrak 2 Cortrak 2 eternal access system However, the incorrect placement of the nasogastric or nasoenteric, tubes can cause severe injury or death.

The company has recall 629 devices, which were distributed in the US from April 1st, 2016 until 1 January 2022.

According to the company's recall notice, there were sixty injuries and 23 deaths in 2015 as a result of the incorrect placement of nasogastric feeding tubes during use of the Cortrak* 2 EAS.

Avanos Mediacal Cortrak 2 Following the recall Avanos Medical will update the labeling of the device. https://prais.paho.org/es/avanos-medical-recalls-cortrak2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm/ This will include an update of the instructions and the planned applications for Cortrak* 2 EAS.

The updated guidelines also instruct users to ensure that the tube is placed according to the institution's protocols before usage.

feeding tube placement The headquarters of Avanos Medical is in Alpharetta Georgia the United States of America. They specialize in manufacturing medical devices. Its brands are sold in more than 90 countries.

In December of last year, the company entered into an agreement to buy OrthogenRx in a $160m deal. https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ Avanos Medical completed the acquisition on January 20.


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