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There are 60 reported injuries and 23 deaths related to this problem.
This is a Class I recall by FDA which is the most serious type. These devices could cause serious injuries and even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 useal access system. Avanos Medical Avanos Medical feeding tube The recall of 629 devices that were distributed from 2016 to 2022 began on the 21st of March.
Cortrak*2 aids clinicians to place medical feeding tubes in the stomach or small bowel of patients who require nutrition through the tube.
This recall was prompted in response to reports of injuries and death in patients following mistakes in the placement of gastric or nasocentric tubes. The device is used to place the tubes. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm An error in inserting the Nasogastric or Nasoenteric tube could cause severe injury or death.
According to Avanos safety communication, this issue has caused 60 injuries and 23 deaths. Avanos Medical feeding tube The adverse events that were mentioned included perforation, respiratory failure, pneumonia, in addition to pleural effusion.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its Cortrak*2 will use the recall to revise its guidelines for use and intended usage. It will advise users to ensure the tube is placed using institutional protocols before delivering nutritional supplements.
Clinicians were also advised to attach the corrected note in the field on the issue to Avanos' operating manual, and to return the acknowledgment forms in Avanos announcement. The company hopes to soon provide users updated labeling. https://zephyrnet.com/sv/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/ This will include confirmation that tube placement was performed in accordance with the institution's policies.
Avanos Mediacal Cortrak 2
My Website: https://zephyrnet.com/sv/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/
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