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This is the reason for the deaths of 60 people and 23 injuries.
The FDA has declared this to be an Class I recall, the most severe type of recall. These devices could 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 accessibility system. 629 devices, distributed from 2016 - 2022, were recalled by U.S. starting on March 21.
Avanos Mediacal Cortrak 2 Cortrak*2 aids clinicians to place medical feed tubes on patients that require nutrition via the tube.
Cortrak 2 eternal access system This recall was initiated in response to reports of injuries and deaths in patients due to misplacement of nasocentric or gastric tubes. The device is used to position the tubes. Incorrectly inserting the Nasogastric or Nasoenteric tube could cause severe injury or even death.
According to AvanosSafety Communication there were 60 deaths and 23 injuries resulting from this issue. The adverse events that were reported include pneumothorax, respiratory failure, perforation, pneumonia and the development of pleural effusion.
Cortrak*2 is using this recall to improve its instructions for usage and intended use. Users will need to verify the location of the tubes according to the protocols of institutions before they can be used to provide nutrition.
Avanos Mediacal Cortrak 2 Clinicians were advised to attach the corrective notice for field use concerning the issue to their operating manual and return the acknowledgement form that was enclosed in the notice to Avanos. https://dohabb.com/index.php?page=user&action=pub_profile&id=1634221 Users will soon receive updated labels and confirmation that tubes were placed according to institution policy.
Avanos Medical
Website: https://www.metooo.io/u/636cdc4db0716d7b0476b09f
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