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This issue has caused more than 23 deaths and 60 injuries.
This is an item classified as a Class I recall by FDA, which is the most serious type. These devices could cause serious injuries and even death.
https://www.inventables.com/users/pachecolausten0019 Sam Brusco, Associate Editor05.16.22
The FDA has discovered Avanos Medical’s recall of their Cortrak*2 intramuscular access system. 629 devices, distributed between 2016 - 2022, were recalled by the U.S. starting on March 21.
Cortrak*2 aids clinicians to place medical feed tubes in patients who require nutrition via the tube.
In the wake of deaths and injuries, the system was recalled. feeding tube placement An error in inserting the Nasogastric or Nasoenteric tube could result in severe injuries or even death.
https://classifieds.lt/index.php?page=user&action=pub_profile&id=3139987 According to Avanos Safety communications, there were 60 injuries and 23 fatalities related to this issue. Pneumothorax (perforation), pneumothorax (perforation) and pneumonia and pleural effusion were all identified as adverse events.
Cortrak*2 will use this recall to revise its instructions for use and intended uses. The users will have to confirm the placement of tubes based on institutional protocols, before they can be used to provide nutrition.
Clinicians were advised to add the corrective field notice regarding the issue to their operating manuals and return the acknowledgment form that was enclosed with the notice to Avanos. https://www.ted.com/profile Avanos is hoping to give users with an updated labels. This includes confirmation that tube placement was performed in accordance with the institution's policy.
Avanos Medical
Homepage: https://www.ted.com/profile
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