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There were 60 injuries as well as 23 deaths due to this problem.
This is an item classified as a Class I recall by FDA, which is the most severe type. The devices could result in serious injuries and even death.
Cortrak 2 eternal access system Sam Brusco Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall of its Cortrak*2 oral access device. 629 devices manufactured between 2016 until 2022 were recalls within the U.S., beginning on the 21st of March.
Avanos Medical Cortrak*2 helps clinicians place medical feeding tubes inside the stomach or small bowels of patients that need to be fed via the tube.
The recall of the system was due to the deaths and injuries of patients resulting from misplacement of nasocentric/nasogastric tubes. These tubes are used to aid in insertion. Incorrectly inserting a nasogastric tube or nasoenteric tube can result in grave injury or even death.
https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement Avanos Medical According to Avanos' safety communications, there were 60 injuries and 23 deaths attributed to this incident. Pneumothorax (perforation), pneumothorax (perforation), pneumonia, and pleural effusion have all been reported as adverse events.
Cortrak*2 will utilize the recall process to modify its guidelines for use and intended usage. It will advise users to check the placement of tubes by using protocols established by institutions prior to delivering nutritional supplements.
Clinicians were advised to add the corrective field notice concerning the issue to their operating manual and to return the acknowledgement form which was enclosed in the notice to Avanos. Avanos plans to give users current labeling, and also a confirmation of tube placement in accordance with the institutional guidelines.
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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