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Avanos Medical pulled Cortrak*2 EAS off service following reports of deaths and injuries caused by tube displacements.
The US Food and Drug Administration has classified Avanos Medical’s Cortrak*2 Enteral Access System (EAS), as a Class 1 recall.
https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its A Class I can remember is considered to be the most serious of the three classes.
Avanos Medical called off Cortrak*2, EAS, following injuries and deaths resulting from misplacements of nasogastric tubs.
The device was developed to assist health care workers in placing medical feed tubes for patients.
However, the wrong placement of nasogastric or nasoenteric tubes can damage a patient's vocal cords, lungs or trachea and cause severe injuries or even death.
Overall, the company been able to recall 629 devices sold in the US between April 1st, 2016 and 1 January 2022.
Avanos Medical The recall notification from the company said that 60 patients were injured and 23 of them died as a result of the wrong placement of nasogastric tubes when using Cortrak* 2 EAS.
Avanos Medical Avanos Medical will make the necessary updates to the labelling of the device following the recall. This will include an update of the instructions for use and intended uses of Cortrak* 2 EAS.
Avanos Medical feeding tube These updated guidelines require users to verify tube placement as per the guidelines of the institution's prior use.
Based in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. The brand's name is sold in more than 90 countries.
The company signed an agreement to purchase OrthogenRx for $160 million in December. https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Avanos Medical concluded the acquisition on January 20th.
Homepage: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/
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