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This has resulted in sixty injuries and 23 deaths.
Cortrak 2 eternal access system The FDA has classified this as an Class I recall, which is the most serious kind of recall. Avanos Medical The devices could cause serious injuries, and even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall for the Cortrak*2 oral access system. The recall of 629 devices distributed between 2016 and 2022 started on the 21st of March.
Cortrak*2 assists clinicians in placing medical feeding tubes in the stomach or small bowels of patients who require to be fed by the tube.
Avanos Medical feeding tube Cortrak 2 eternal access system The device was temporarily recalled because of injury and death reports resulting from nasocentric and nasogastric tube misplacement when the device is used to help put these tubes in the right place. An incorrectly placed nasogastric/nasoenteric tube can cause serious injury or death.
Avanos Medical feeding tube According to Avanos' safety communications the number of injuries was 60 and 23 deaths related to this issue. Pneumothorax and pneumothorax (perforation), pneumonia, and pleural effusion have all been reported as adverse events.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause The recall is being leveraged to update Cortrak*2's instructions on use and intended use and instructing users to confirm the placement of the tube based on guidelines for institutions prior to using the tube to distribute nutrition.
Clinicians were also advised to attach the field-correction notice about the issue to the operating manual , and return the acknowledgement form included in the notice to Avanos. The company hopes to soon offer users with updated labels. This will include confirmation that tube placement was performed in accordance with the institution's guidelines.
Website: https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/
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