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The issue has caused at least 60 injuries and 23 deaths.
The FDA has designated this as a Class I Recall, the most severe type. Cortrak 2 eternal access system Avanos Mediacal Cortrak 2 These devices can lead to serious injuries and even death.
feeding tube placement Cortrak 2 eternal access system Sam Brusco Associate Editor05.16.22
The FDA has identified Avanos Medical’s recall for its Cortrak*2 oral access device. 629 devices, distributed from 2016 - 2022, were recalls by the U.S. starting on March 21.
https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Cortrak*2 is a device that allows doctors to place medical feeding tubes inside patients stomachs, or small bowels.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery The system's recall was due to patient deaths and injury following the incorrect placement of nasocentric/nasogastric tubes. These tubes aid in insertion. Avanos Medical feeding tube When you are not careful, inserting a nasogastric tube or nasoenteric tube can result in severe injury, or even death.
According to Avanos Safety communications there were 60 injuries and 23 fatalities related to this incident. The adverse events that were reported include pneumothorax, respiratory failure, perforation, pneumonia, and the development of pleural effusion.
Cortrak*2 is using the recall to make changes to its instructions to use. The updated instructions will contain instructions for users to make sure that tubes are placed in accordance with the guidelines of the institution before making use of them to deliver food.
Clinicians are also advised to include the field correction note to the operating manual and return the acknowledgement form included with the notice to Avanos. Avanos is hoping to provide users with updated labels. This will include confirmation that tube placement was carried out in accordance with institutional policy.
My Website: https://zephyrnet.com/sv/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/
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