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This issue has led to 60 injuries and 23 deaths.
feeding tube placement Avanos Medical feeding tube The recall was classified by the FDA as a Class I recall. It is the most serious type of recall. Avanos Medical feeding tube The use of these devices could result in serious injuries or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the company responsible for recalling its Cortrak*2 system of enteral access. 629 devices, distributed from 2016 and 2022 were recalls by the U.S. starting on March 21.
Avanos Medical feeding tube Avanos Mediacal Cortrak 2 Cortrak*2 helps clinicians place medical feeding tubes into the stomach or small bowels of patients that need to be fed via the tube.
The system was recalled due to injury and patient death reports following nasocentric or Nasogastric tube misplacement while it is employed to to insert these tubes. https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding An incorrectly placed nasogastric/nasoenteric tube can result in severe injury or even death.
Cortrak 2 eternal access system According to Avanos safety communication the issue has resulted in sixty injuries and 23 deaths. Avanos Medical Pneumothorax (perforation), pneumothorax (perforation) pneumonia, and pleural effusion were all reported as adverse events.
The recall is being used to revise Cortrak*2's guidelines regarding use and intended usage, instructing users to confirm the placement of the tube according to protocol guidelines before using the tube to deliver nutrition.
Clinicians are also advised to attach the field correction notice to the operating guideline and return the acknowledgement form included in the notice to Avanos. The company is planning to offer users the most current labels, and also a confirmation of the placement of the tube according to the policies of the institution.
Read More: https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html
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