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Avanos Medical called off Cortrak* 2 EAS in response to the patient injury and deaths caused by tube malfunctions.
Avanos Medical feeding tube The US Food and Drug Administration (FDA) has identified the recall issued by Avanos Medical of Cortrak*2 Ental Access System, (EAS) as an class I recall.
The term "Class I Recall" refers to the most severe of the three classes.
Avanos Medical recalls Cortrak*2 EAS following reports of injuries and death due to the wrong placement of nasogastric and nasoenteric tubes.
The device was designed to aid trained health care workers in placing medical feed tubes for patients.
However, incorrectly installed nasogastric/nasoenteric pipe can cause damage to vocal cords, or the trachea. This could result in grave injuries or even death.
https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm The company has since recalled 629 devices from the US that were sold between April 1, 2016 and 1 January 2022.
Avanos Medical feeding tube The communication regarding the recall from the company also stated that there have been 60 injuries and 23 deaths of patients since the year 2015 due to misplacement of Nasogastric feeding tubes that were used with the Cortrak* 2 EAS.
Avanos Medical will revise the labelling after the recall. https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical This includes changing the instructions for Cortrak*2 EAS as well as its intended uses.
Avanos Medical feeding tube Users are also advised to verify that tubes have been placed according to protocols of the institution prior to use.
Avanos Medical's headquarters is located in Alpharetta Georgia the United States of America. They are a specialist in the production of medical devices. Its brands are sold in over 90 countries.
The company signed a $160 million agreement in December of last year to acquire OrthogenRx. Avanos Medical closed on the acquisition in January.
Here's my website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
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