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Avanos Medical called off Cortrak* 2 EAS as a result of patient deaths and injuries caused by tube displacements.
The US Food and Drug Administration (FDA), has designated the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as an I class recall.
The term "Class I Recall" is a reference to the most severe of three classes.
feeding tube placement Avanos Mediacal Cortrak 2 Avanos Medical called off Cortrak* 2, EAS, after deaths and injuries that resulted from the misplacement of nasogastric tubs.
This device can be used to assist trained health care professionals in placing medical feeding tubes in patients. It also provides real-time information about tube placement.
But, improperly installed nasogastric/nasoenteric pipe can cause damage to vocal cords, or the trachea. This could lead to severe injuries, or even death.
The company has recalled 629 devices from the US which were distributed between April 1st, 2016 and 1 January 2022.
The recall notice from the company stated that 60 patients were injured and 23 were killed due to incorrect placement in nasogastric tube while using Cortrak* 2 EAS.
feeding tube placement Avanos Medical feeding tube Avanos Medical will make the necessary updates to the labeling of the device in the wake of the recall. This includes updating the instructions and intended applications of Cortrak* 2 EAS.
The revised guidelines also direct users to ensure that the tube is placed in accordance with the institution's guidelines prior to using.
Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. Avanos Medical sells its products in over 90 different countries.
Avanos Medical feeding tube The company came to an agreement with OrthogenRx to purchase the company in a $160m deal. Avanos Medical completed the acquisition on January 20.
Avanos Medical
Website: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system
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