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This problem has resulted in 60 injuries and 23 deaths.
The FDA has classified this as a Class I Recall, which is the most serious type. These devices could lead to severe injuries or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 user access system. 629 devices manufactured between 2016 and 2022 were recalled, the first recall taking place on March 21.
Avanos Mediacal Cortrak 2 Cortrak*2 assists clinicians in placing medical feed tubes in patients who require nutrition through the tube.
The system was recalled because of injury and deaths resulting from nasocentric or Nasogastric tube misplacement while the device is used to to insert these tubes. An incorrectly placed nasogastric/nasoenteric tube can result in severe injury or even death.
According to Avanos reports, there were more than 60 injuries and 23 deaths in connection with this issue. Adverse events reported included pneumothorax, respiratory failure perforation, pneumonia, as well as the pleural effusion.
Avanos Medical feeding tube Avanos Medical Cortrak*2 is using the recall process to make revisions to its procedures for its use. Avanos Medical Cortrak 2 eternal access system The new instructions include instruction to users to verify that tubes are placed according to the guidelines of the institution before applying them to provide nutrition.
Cortrak 2 eternal access system Clinicians were instructed to add the relevant field correction notice in the operating manual. They must also return the acknowledgement sheet included with the Avanos notification. https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical Avanos plans to offer users updated labeling, including confirmation of tube placement as per the policies of the institution prior to use.
My Website: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system
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