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This issue has been responsible for the deaths of 60 and 23 injuries.
This recall is classed by FDA as a class I recall. Avanos Mediacal Cortrak 2 This is the most serious type. These devices can cause severe injuries or even death.
Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical’s recall of their Cortrak*2 intramuscular accessibility system. 629 devices, which were distributed between 2016 - 2022, were recalled by U.S. starting on March 21.
https://setiweb.ssl.berkeley.edu/beta/show_user.php?userid=10940204 Cortrak*2 permits clinicians to insert medical feeding tubes inside the stomach or small bowel of patients that require nutrition.
This recall was prompted in response to reports of injuries and deaths in patients due to misplacement of nasocentric or gastric tubes. The device is used to position the tubes. https://www.ted.com/profile If a nasogastric, or nasoenteric tube is incorrectly inserted it can cause damage to the vocal cords, lungs or trachea, which can result in grave injury or even death.
According to Avanos reports, there were a total of 60 injuries and 23 deaths related to this issue. Pneumothorax, pneumothorax (perforation) and pneumonia and pleural effusion were all identified as adverse events.
Cortrak 2 eternal access system Avanos Medical Cortrak*2 is using this recall to update the guidelines for usage and intended use. The users will have to verify the location of tubes based on established protocols before they can deliver nutrition.
Avanos Mediacal Cortrak 2 Clinicians were advised to attach the corrective field note concerning the issue to their operating manual and return the acknowledgement form which was enclosed with the notification to Avanos. The company aims to soon give users an current labeling, which will include confirmation of the placement of tubes as per the policies of the institution prior to the use.
My Website: https://setiweb.ssl.berkeley.edu/beta/show_user.php?userid=10940204
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