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Avanos Medical recalls Cortrak*2 EAS in the wake of reports of injury and deaths due to tube incorrect placement.
The US Food and Drug Administration has identified the Cortrak*2 of Avanos Medical's enteral access system (EAS), for recall as a Class II recall.
A Class I recall is a reference to the most severe of the three classes.
Avanos Medical recalls Cortrak*2 EAS after reports of injuries and even death caused by incorrect placements of nasogastric or nasal tubes.
This device can be used to aid trained healthcare professionals to insert medically-approved feeding tubes for patients. https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ feeding tube placement It also provides in real-time information about tube placement.
However, the wrong positioning of nasogastric or nasal tubes could cause damage to the vocal cords of patients and trachea or lungs and cause severe injuries or death.
The company recalls 629 devices, which were made available across the US from April 1st, 2016 to 1 January 2022.
The recall notification from the company said that 60 patients were injured and 23 died due to the wrong placement of nasogastric tubes when using Cortrak* 2 EAS.
Avanos Medical will revise the labelling after the recall. This includes updating Cortrak*2 EAS's instructions and intended uses.
feeding tube placement Users should also verify that tubes have been placed according to protocols of the institution before they make use of them.
Avanos Medical's headquarters is located in Alpharetta Georgia the United States of America. They are a specialist in the production of medical equipment. It sells its brands across more than 90 countries.
The company agreed to buy OrthogenRx for $160 million in December. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Avanos Medical concluded the acquisition on 20th January.
My Website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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