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The issue has caused at the very least 60 injuries and 23 deaths.
This recall was identified by the FDA as a Class I recall. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm It is the most severe form of recall. These devices can cause serious injuries, or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has discovered Avanos Medical's recall of their Cortrak*2 intramuscular access system. The recall of 629 devices distributed between 2016-2022 began on the 21st of March.
Cortrak*2 helps clinicians place medical feeding tubes into the stomach or small bowels of patients who need to be fed through the tube.
Cortrak 2 eternal access system The recall was caused by reports of death and injuries from patients who suffered from nasocentric or nasogastric mistaken placement. This device is utilized for helping to place these tubes. A mistake in the placement of a Nasogastric or Nasoenteric tube could cause severe injury or death.
https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical As per Avanos safety communication the issue has resulted in sixty injuries and 23 deaths. There were several adverse events, including respiratory failure, pneumothorax and perforation as well as pleural effusion and pneumonia.
Cortrak*2 is using the recall to make updates to its instructions for use. The updated instructions will provide users with a way to ensure that the tubes are placed according to the guidelines of the institution before using them to deliver nutrition.
Avanos Medical Clinicians are also advised to include the field correction notice about the issue to the operating guideline and return the acknowledgement forms included with the notification to Avanos. The users will shortly receive an update to the labels and confirmation that the tubes were placed according to institution policy.
My Website: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm
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