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The issue has caused at the very least 60 injuries and 23 deaths.
feeding tube placement The FDA has declared this to be an Class I recall, the most serious type of recall. These devices could cause serious injuries, or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 access device for use in the system. Beginning on March 21 the 21st of March, 2016, 629 devices were recalled in the U.S.
Avanos Medical feeding tube Cortrak*2 helps clinicians place medical feeding tubes inside the stomach or in the small bowel of patients who require nutrition via tube.
Avanos Medical feeding tube Due to injuries and deaths due to injuries and deaths, the system was recall. Nasogastric, also known as nasoenteric, tube that is not correctly inserted could result in damage to the vocal chords or the trachea. This could lead to severe injury or death.
According to Avanos Safety communications there were 60 injuries and 23 deaths attributed to this issue. https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ Adverse events reported included pneumothorax, respiratory failure, perforation, pneumonia, and pleural effusion.
https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ This recall will be used to revise Cortrak*2's instructions for use, intended uses, and instruct users to confirm tube placement in accordance with institutional guidelines prior to using the tube in order to deliver nutritional benefits.
Clinicians were urged to attach the corrective notice for field use regarding the issue to their operating manual and return the acknowledgment form that was included with the notification to Avanos. The company will soon be able to provide updated labels to patients, as well as confirmation of the tube's placement according to the policies of the institution.
Here's my website: https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/
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