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This issue has led to sixty injuries and 23 deaths.
The FDA has classified this as an Class I Recall, the most serious kind. Use of these devices may cause serious injury or death.
Sam Brusco Associates Editor05.16.22
The FDA has discovered Avanos Medical's recall of Cortrak*2 enteral access system. 629 of the devices produced between 2016 and 2022 were recalled, the first recall taking place on March 21.
Cortrak*2 assists clinicians in placing medical feeding tubes inside the stomach or small bowels of patients that need to be fed through the tube.
Avanos Medical feeding tube The device was temporarily recalled because of injury and deaths resulting from nasocentric or Nasogastric tube misplacement while it is employed to help place these tubes. https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/ If a nasogastric, or nasoenteric tube is inserted incorrectly there could be damage to the vocal cords, lungs or trachea, which can result in serious injury or death.
https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ According to Avanos’ safety communication the number of deaths was 60 and 23 injuries related to this problem. Many adverse events were reported, including respiratory failure, pneumonia and pneumothorax.
feeding tube placement Avanos Mediacal Cortrak 2 Avanos Medical The recall is used to revise Cortrak*2's guidelines regarding use and intended usage and instructing users to confirm tube placement based on protocol guidelines before using the tube to deliver nutrients.
Avanos Mediacal Cortrak 2 Clinicians were also encouraged to attach the amended note in the field on the problem to Avanos operating manual and to return the acknowledgment forms included with Avanos' announcement. feeding tube placement Avanos hopes to provide users with updated labels. This includes confirmation that tube placement was done according to institutional policies.
Here's my website: https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/
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