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This is the reason for the deaths of 60 people and 23 injuries.
This is an item classified as a Class I recall issued by FDA which is the most serious type. The devices could result in serious injuries and even death.
Avanos Medical Sam Brusco, Associate Editor05.16.22
The FDA has discovered Avanos Medical's recall of its Cortrak*2 intramuscular access device. 629 devices, distributed from 2016 and 2022, were recalled by U.S. starting on March 21.
feeding tube placement Cortrak*2 assists clinicians in placing medical feeding tubes inside the stomach or in the small bowels of patients who require nutrition through the tube.
Avanos Mediacal Cortrak 2 This recall was prompted due to reports of injury and deaths in patients due to mistakes in the placement of gastric or nasocentric tubes. The device is used to insert these tubes. A mistake in the placement of an Nasogastric tube or Nasoenteric one could result in severe injury or death.
Cortrak 2 eternal access system According to AvanosSafety Communication the number of deaths was 60 and 23 injuries resulting from the issue. Some of the adverse events reported were respiratory failure, pneumothorax, perforation, pneumonia, as well as the pleural effusion.
feeding tube placement Cortrak 2 eternal access system The recall is being leveraged to modify Cortrak*2's directions regarding use and intended usage and instructing users to confirm tube placement based on institutional protocols before using the tube to distribute nutrition.
Clinicians were also asked to attach the correction notice concerning the issue in the operating book and return the acknowledgement form with the notification to Avanos. Avanos Mediacal Cortrak 2 Avanos hopes to offer users with updated labels. This will include confirmation that tube placement was done according to institutional policies.
Avanos Medical feeding tube
Homepage: https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system
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