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This issue has led to sixty injuries and 23 deaths.
This is a Class I recall by FDA, which is the most severe type. Utilizing these devices can cause serious injury or death.
https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Sam Brusco Associate Editor05.16.22
The FDA has identified Avanos Medical as the one responsible for recalling its Cortrak*2 system of enteral access. 629 devices manufactured between 2016 until 2022 were recalls, with the first recall occurring on March 21.
Cortrak 2 eternal access system Cortrak*2 assists clinicians in placing medical feeding tubes in the stomach or small bowels of patients that need to be fed via the tube.
The recall was triggered by reports of death and injuries of patients suffering from nasocentric/nasogastric tube misplacement. Avanos Medical This device is used to aid in the placement of the tubes. A mistake in the placement of the Nasogastric or Nasoenteric tube could result in severe injury or even death.
According to AvanosSafety Communication, there were 60 deaths and 23 injuries related to this problem. There were several adverse events, such as respiratory failure, pneumothorax and perforation, pneumonia and pleural effusion.
Cortrak*2 will make use of the recall process to modify its instructions for usage and intended usage. It will also instruct users to ensure the tube is placed using institutional protocols before delivering nutrition.
Clinicians are also advised to include the field correction notice to the operating manual , and return the acknowledgement forms included with the notification to Avanos. Cortrak 2 eternal access system Avanos Mediacal Cortrak 2 Avanos hopes to offer users with updated labels. This will include confirmation that the placement of the tube was done according to institutional policy.
Homepage: https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas
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