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Avanos Medical called off Cortrak* 2 EAS in response to patient deaths and injuries caused by tube displacements.
The US Food and Drug Administration has identified Avanos Medical’s Cortrak*2 enteral access system (EAS) as a recall as Class II recall.
Avanos Mediacal Cortrak 2 A Class I can remember is considered to be to be the most important of all three classes.
Avanos Medical pulled Cortrak* 2 EAS out of service due to patient deaths and injuries due to misplacements of nasogastric tubes.
This device can be used to assist trained health professionals with the placement of medically-approved feeding tubes for patients. It also provides real-time information about tube placement.
But, incorrect placement of the nasogastric/nasoenteric tubs result in severe injuries or even death.
feeding tube placement Overall, the company recalled 629 devices that were sold in the US between April 1st, 2016 to 1 January 2022.
https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 According to the company's recall communication it was reported that there were 53 deaths and 60 injuries during 2015 because of the incorrect placement of nasogastric feeding tubes during use of the Cortrak* 2 EAS.
Following the recall Avanos Medical will update the device's labelling. This will include an update of the instructions for use and intended uses of Cortrak* 2 EAS.
The updated guidelines instruct users to ensure that the tube has been installed in accordance with the guidelines of their institution prior usage.
Avanos Medical is based in Alpharetta (Georgia) in the United States. It specializes in manufacturing medical equipment. It sells its brands in over 90 different countries.
The company reached an agreement with OrthogenRx to purchase the company for $160 million in a deal. Avanos Mediacal Cortrak 2 Avanos Medical successfully closed the acquisition of OrthogenRx in January.
Read More: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical
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