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This issue has led to 60 injuries and 23 deaths.
This is an item classified as a Class I recall by FDA, which is the most severe type. https://lexsrv3.nlm.nih.gov/fdse/search/search.pl?match=0&realm=all&terms=https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html The use of these devices could result in serious injuries or even death.
feeding tube placement Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical’s recall for its Cortrak*2 oral access system. 629 devices distributed between 2016 to 2022 were recalled in the U.S., beginning on March 21.
https://500px.com/p/mayspmlvogel Cortrak*2 helps clinicians place medical feeding tubes inside the stomach or small bowels of patients that need to be fed through the tube.
feeding tube placement The recall was initiated due to reports of injury and death in patients following misplacement of nasocentric or gastric tubes. The device is used to insert these tubes. http://www.clacker.com.au/index.php?page=user&action=pub_profile&id=1321117 Nasogastric, also known as the nasoenteric tube, that isn't properly inserted could result in damage to the vocal cords or the trachea. This could lead to serious injury, or even death.
According to AvanosSafety Communication, there were 60 deaths and 23 injuries that were related to this issue. Avanos Medical Adverse events reported included pneumothorax, respiratory failure, perforation, pneumonia and pleural effusion.
The recall is being used to update Cortrak*2's instructions on use and intended use and to instruct users to verify the placement of the tube based on protocol guidelines before using the tube to deliver nutrition.
Clinicians were requested to attach the correct notice concerning the issue in the operating book and then return acknowledgment forms along with the notice to Avanos. Avanos plans to give users an current labeling, which will include confirmation of the placement of tubes as per the policies of the institution prior to usage.
My Website: http://www.clacker.com.au/index.php?page=user&action=pub_profile&id=1321117
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