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The Avanos Medical Cortrak*2 Ental Access System was created to assist trained healthcare professionals to insert medical feeding tubes in patients' small intestines or stomachs. There have been 23 deaths reported to date due to feeding tubes since 2015.
Numerous reports have shown that patients have sustained injuries or even passed away after their nasogastric and nasoenteric tubes were not properly placed. This is despite the fact that this device was utilized to aid in the placement.
This recall is used to make changes to the labeling of the device, which includes the instructions for usage and the intended usage. Avanos Medical Users are instructed to verify that the tube has been placed according to the protocols of their institution before applying it to provide nutrition.
Patients may suffer serious injury or death from incorrectly inserted Nasogastric tubes and nasoenteric ones.
Avanos Medical feeding tube Avanos Medical's recall notification declared that there were 60 injuries and 23 deaths linked to the misplacement or removal of the nasogastric feed tube during using the CORTRAK*2 enteral Access System. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview This occurred from the year 2015. Pneumothorax, respiratory failure perforation (a hole, in the stomach wall) and pneumonia were all mentioned.
Cortrak 2 eternal access system Avanos Medical Avanos Medical issued on March 21, 2022, a field correction notice to customers who were using the devices between January 20,21 and January 20,22. These instructions were included in the notice:
Confirm placements of nasogastric/nasoenteric tubes in accordance with institutional policies
Add the notice of correction for field regarding the issue to the operator's handbook.
Cortrak 2 eternal access system Avanos must acknowledge receipt of the email message.
Read More: https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges
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