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There are 60 reported injuries and 23 deaths due to this issue.
Avanos Medical This recall has been identified by the FDA as an Class I recall. It is the most severe type of recall. https://www.cyberera.com.ng/2022/05/17/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ These devices can cause severe injuries or even death.
https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Sam Brusco, Associate Editor05.16.22
The FDA has discovered Avanos Medical's recall of its Cortrak*2 entry access system. Avanos Medical feeding tube The recall of 629 devices distributed between 2016-2022 began on the 21st of March.
Cortrak 2 eternal access system Cortrak*2 lets clinicians insert medical feeding tubes in the small bowel or stomach of patients who require nutritional assistance.
The device was temporarily recalled because of injury and deaths resulting from nasocentric or nasogastric tube misplacement when the device is used to help put these tubes in the right place. Improperly inserting a tube for nasogastric or nasoenteric one can cause grave injury and even cause death.
According to Avanos safety communication, this issue has caused sixty injuries and 23 deaths. The adverse events reported included pneumonia, perforation, respiratory failure, and pneumonia, in addition to pleural effusion.
Cortrak*2 will make use of the recall to update its guidelines for use and intended uses. It will instruct users to ensure the tube is placed with the help of institutional protocols prior to providing food.
Clinicians were also asked to attach the correction notice concerning the issue in the operating book, and return the acknowledgement form with the notice to Avanos. Avanos will shortly be able provide the latest labeling for users, which will include confirmation of tube placement according to the policies of the institution.
Homepage: https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/
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