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Avanos Medical called off Cortrak* 2 EAS as a result of patient death and injuries caused by tube displacements.
Avanos Medical The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak*2 Enteral Access System (EAS) as a Class I recall.
A Class I remember is considered to be to be the most important of the three classes.
Avanos Medical recalled Cortrak* 2 EAS following reports of injuries and patient deaths caused by nasoenteric and Nasogastric tube misplacements.
The device is intended to aid trained health care personnel place medical tube feedings in patients and offer real-time location information on tube placement.
However, incorrectly placed nasogastric/nasoenteric pipes could result in damage to vocal cords, or the trachea. This can lead to serious injuries or even death.
The company recalls 629 devices sold throughout the US between January 2016 to January 2022.
Avanos Mediacal Cortrak 2 The company also stated in a recall notice that there were 60 injuries and 23 patients killed since 2015 because of the misplacement nasogastric feed tubes when using the Cortrak* 2 EAS.
Cortrak 2 eternal access system Avanos Medical will revise the labelling in the wake of the recall. Avanos Medical feeding tube This includes updating the directions on how to use the device as well as intended uses of Cortrak*2 EAS.
These revised guidelines direct users to verify tube placement as per the guidelines of the institution's prior use.
Avanos Medical has its headquarters in Alpharetta Georgia. Its brands are sold in over 90 countries.
The company came to an agreement with OrthogenRx to acquire the company for $160 million in a deal. Avanos Medical closed on the acquisition in January.
https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm
Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
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