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Avanos Medical called off Cortrak* 2 EAS in response to patient deaths and injuries caused by tube displacements.
https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement Avanos Medical The US Food and Drug Administration (FDA) has designated the recall issued by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as an class I recall.
A Class I remember is considered to be the most serious out of the three classes.
Avanos Medical pulled Cortrak* 2 EAS out of service due to death and injuries of patients due to nasogastric tube misplacements.
Avanos Mediacal Cortrak 2 This device can be used to assist trained healthcare professionals to insert medical feeding tubes into patients. It also provides in real-time information regarding tube placement.
Incorrect placement of nasogastric and nasoenteric tube can result in serious injuries or death.
The company has recall 629 devicesthat were distributed across the US from April 1st, 2016 until 1 January 2022.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause The company also noted in a recall notice that there had been 60 injuries and 23 patients killed since 2015 because of the incorrect placement of nasogastric feed tubes when using the Cortrak* 2 EAS.
https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 In the wake of the recall, Avanos Medical will update the labeling of the device. This will include changing the instructions as well as the intended applications of Cortrak* 2 EAS.
The revised guidelines also require users to ensure that the tube is placed in accordance with the institution's guidelines prior to using.
Avanos Medical has its headquarters in Alpharetta Georgia. The company has more than 90 markets for its recognized brands.
In December Avanos Medical entered into an agreement worth $160 million to purchase OrthogenRx. Avanos Medical concluded the acquisition on January 20th.
Read More: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement
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