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There have been 60 injuries and 23 deaths due to this issue.
https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview The recall is classified by FDA as a class I recall. Avanos Mediacal Cortrak 2 Cortrak 2 eternal access system Cortrak 2 eternal access system This is the most serious form of recall. These devices could lead to grave injuries, or even death.
Sam Brusco Associate Editor05.16.22
The FDA has discovered Avanos Medical’s recall of their Cortrak*2 intramuscular accessibility system. 629 of the devices produced between 2016 to 2022 were recalled with the first recall happening on March 21.
Cortrak*2 assists clinicians in placing medical feed tubes on patients that require nutrition via the tube.
Due to the possibility of injuries or deaths caused by the system, it was removed. A mistake in the placement of the Nasogastric or Nasoenteric tube can cause serious injuries or even death.
According to Avanos' safety communications, there were 60 injuries and 23 fatalities related to this incident. Cortrak 2 eternal access system The adverse events that were mentioned included perforation, respiratory failure, pneumonia, in addition to the pleural effusion.
This recall will be used to update Cortrak*2’s instructions regarding use, intended usage and also instruct users to confirm tube placement as per institutional guidelines prior to using the tube to deliver nutrition.
Clinicians were also encouraged to attach the corrected field notice on the issue to Avanos operating manual and to return the acknowledgment forms included in Avanos announcement. https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ Users will soon receive updated labels and confirmation that tubes were placed in accordance with institution guidelines.
My Website: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview
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