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This issue has caused more than 23 deaths and 60 injuries.
This recall has been identified by the FDA as a Class I recall. Cortrak 2 eternal access system It is the most severe form of recall. These devices can cause grave injuries, or even death.
https://www.newsbreak.com/news/2607393691988/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i Sam Brusco is Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of the Cortrak*2 useal access system. 629 devices manufactured between 2016 to 2022 were recalled within the U.S., beginning on March 21.
Avanos Mediacal Cortrak 2 Cortrak*2 assists clinicians in placing medical feeding tubes in the stomach or small bowels of patients who need to be fed via the tube.
The system was recalled because of injury and death reports following nasocentric or Nasogastric tube misplacement while the device is used to put these tubes in the right place. Avanos Medical An incorrectly placed nasogastric/nasoenteric tube can cause serious injury or even death.
According to Avanos Safety communications there were 60 injuries and 23 deaths attributed to this issue. Cortrak 2 eternal access system There were several adverse events, including pneumothorax, respiratory failure and perforation as well as pleural effusion and pneumonia.
The recall is used to revise Cortrak*2's guidelines for use and intended uses, instructing users to confirm tube placement based on institutional protocols before using the tube to distribute nutrition.
Clinicians were instructed to add the relevant field correction notice in the operating manual. Avanos Medical They must also return the acknowledgement sheet that came with the Avanos note. The company is expected to be able provide the latest labeling for users, which will include confirmation of the placement of tubes according to the policies of the institution.
Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
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