Notes

Avanos Medical recalls the Cortrak*2 enteral access system
Avanos Medical, a U.S. Food and Drug Administration (FDA) company recalls Cortrak*2 enteral access system due to misplacement nasoenteric tubes or nasogastric tubs that could have caused injuries and even deaths of patients. Avanos Mediacal Cortrak 2 The recall currently covers 629 devices that were distributed across the United States.

Avanos selling the Cortrak*2 Endural Access System has been primarily for its screen-based visualizations of patients' stomachs and small bowels to assist in the placement medical feeding tubes. When a tube is placed incorrectly, it could result in damage to the vocal cords, lungs and trachea. Avanos Medical recalls that there have been sixty injuries, 23 deaths and 23 illnesses resulting from the incorrect placement or accidental insertion of a nasogastric feeding tube using the CORTRAK*2 Enteral Access System. These injuries include respiratory failure pneumothorax (collapsed lung), perforation (a hole in the lung's wall, esophagus, or the bowel), pneumonia, and the pleural effusion (excess fluid in the chest cavity and the lungs).

Avanos Medical described a plan for users to receive updated labeling to confirm proper placement of the nasogastric tubes and nasoenteric pipes before use

The Avanos warning was the second FDA warning issued in 2022 about tube feeding for enteral use. In February, parents and healthcare professionals were warned by the FDA about the potential for strangulation of children who use feeding tubes. https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Cortrak 2 eternal access system Two deaths of children from strangulation were reported in 2021, as a result of a tube device that was wrapped around the neck of a patient.

Avanos Mediacal Cortrak 2 FDA Recalls Avanos Medical Device

The Risks of Enteral Feeding Delivery Sets

Cortrak* 2 Enteral Access System Product Details

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