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Avanos Medical recalls Cortrak*2 EAS in the wake of reports of injury and even death caused by tube misplacements.
The US Food and Drug Administration has identified the Cortrak*2 of Avanos Medical's enteral access system (EAS), for recall as Class II recall.
https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement A Class 1 recall is the most serious of three classes.
Avanos Medical called off Cortrak* 2, EAS following injuries and deaths resulting from the misplacement of tubs for nasogastric surgery.
The device allows skilled healthcare professionals to insert medical feeding tubes in patients.
However, incorrectly placed nasogastric/nasoenteric tubes could cause harm to vocal cords or trachea. This could result in grave injuries or even death.
Avanos Medical feeding tube Overall, the company has recalled 629 devices that were sold in the US between 1 April 2016 and 1 January 2022.
The company also stated in a recall announcement that there have been sixty injuries and 23 people killed since 2015 because of the incorrect placement of nasogastric feed tubes in the Cortrak* 2 EAS.
Avanos Medical is updating the labelling on the device after the recall. This will include updating the instructions for use and intended usages of Cortrak*2 EAS.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause The revised guidelines also require users to verify the placement of their tubes based on the respective institution's protocols before usage.
The headquarters of Avanos Medical is in Alpharetta Georgia the United States of America. They specialize in manufacturing medical devices. Cortrak 2 eternal access system https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 It sells its brands in more than 90 different countries.
Cortrak 2 eternal access system The company entered into a $160m agreement last December to acquire OrthogenRx. Avanos Medical closed the acquisition on January 20th.
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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