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This problem has resulted in 60 injuries and 23 deaths.
Avanos Medical This is a Class I recall by FDA which is the most serious kind. Avanos Mediacal Cortrak 2 These devices can cause serious injuries or even death.
Avanos Medical feeding tube Sam Brusco Associates Editor05.16.22
The FDA has discovered Avanos Medical's recall of its Cortrak*2 enteral access system. 629 devices manufactured between 2016 to 2022 were recalled with the first recall occurring on the 21st of March.
Cortrak*2 allows clinicians to place medical feeding tubes in the stomach or small bowel of patients who require nutrition.
The device was removed due to injury and patient death reports following nasocentric or Nasogastric tube misplacement while the device is used to help to insert these tubes. If a nasogastric or nasoenteric tube is inserted incorrectly there could be damage to the vocal cords, lungs or the trachea, leading to grave injury or even death.
https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ According to Avanos the number of incidents has been more than 60 injuries and 23 death connected to this problem. Cortrak 2 eternal access system Adverse events reported included respiratory failure, pneumothorax, perforation, pneumonia, as well as the pleural effusion.
The recall is being leveraged to update Cortrak*2's instructions on use and intended use and to instruct users to verify tube placement based on protocol guidelines before making use of the tube to provide nutritional supplements.
Clinicians were also urged to attach the amended field notice regarding the issue to Avanos' operating manual, and return the acknowledgement forms that came in Avanos announcement. Cortrak 2 eternal access system Avanos hopes to give users updated labeling. This includes confirmation that tube placement was carried out in accordance with institutional guidelines.
Read More: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding
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