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Avanos Medical recalls Cortrak*2 EAS after reports of injury and death due to tube malfunctions.
https://aacnjournals.org/ajcconline/article/29/1/22/30624/Pneumothoraces-Prevented-With-Use-of The US Food and Drug Administration has confirmed the Cortrak*2 of Avanos Medical's Enal Access System Recall (EAS) in Class I recall.
A Class 1 recall is the most serious of the three classes.
https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths from nasogastric tube misplacements.
The device is designed to help healthcare professionals with training to insert medical tubes for feeding within patients, and provide real-time location information on tube placement.
Cortrak 2 eternal access system However, incorrectly placed nasogastric/nasoenteric tubes could result in damage to the vocal cords or trachea. https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ This can lead to severe injuries, or even death.
Cortrak 2 eternal access system The company has since recalled 629 devices from the US that were sold between 1 April 2016 - 1 January 2022.
The recall notice from the company stated that 60 patients suffered injuries and 23 died due to the wrong placement of nasogastric tubes when making use of Cortrak* 2 EAS.
Avanos Medical will revise the labelling in the wake of the recall. This will include updating the instructions and intended applications of Cortrak* 2 EAS.
Revisioned guidelines require users to confirm the position of tubes in accordance with protocols issued by their institutions before making use of them.
Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on making medical devices for clinical use. The company's products are distributed across more than 90 countries.
Avanos Medical feeding tube Avanos Mediacal Cortrak 2 The company reached an agreement with OrthogenRx to purchase the company for $160 million in a deal. Avanos Medical concluded the acquisition on 20th January.
My Website: https://www.medscape.com/viewarticle/891200
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