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Avanos Fails FDA Class 1 Recall Resulting in 23 deaths attributed to the Device

 The Avanos MedicalCortrak*2 Enteral Access System is designed to help healthcare professionals with training to insert medical feeding tubes in the small bowel or stomach of patients who need to be fed via the tube. https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/ There have been 23 deaths related to the feeding tube since 2015. Many reports have revealed that patients have sustained trauma or even died when their nasogastric tubes or nasoenteric ones were not properly placed. https://www.raps.org/regulatory-focus™/news-articles/2018/1/fda-warns-doctors-of-collapsed-lungs-and-deaths-possibly-linked-to-feeding-tube-placement-devices It's despite the fact that this device was used to aid in their placement. This recall is utilized to make changes to the labeling of the device, which includes the instructions to use. The updated instructions instruct users to verify that the tube is placed according to their institution's protocols prior to using the tube for nutrition delivery. Avanos Medical The incorrect placement of a Nasogastric or Nasoenteric tube may result in damage to the vocal cords, lungs, or the trachea. This can lead to serious injury and even the death. Cortrak 2 eternal access system Avanos Medical recalls that there has been a total of 60 incidents and 23 deaths resulting from mistakes in the placement of nasogastric tubes in the last year. There were several adverse events that occurred, including respiratory failure, pneumothorax (collapsed lungs) as well as perforation (a hole or opening in the wall of the esophagus or the bowel), pneumonia, and the pleural effusion (excess liquid that has accumulated in the space between your lungs and chest cavity). Avanos Medical Avanos Medical feeding tube On the 21st of March 2022 Avanos Medical issued a field correction notice to customers who used these devices between January 2021 and January 2022. https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas The notice contained the following information: Confirm placement of nasogastric and the nasoenteric tube according to institution guidelines. Attach the appropriate note of correction to the field in the operator’s guide. Avanos Health Medical asks that you return the acknowledgement form with the email notice

https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/|https://www.raps.org/regulatory-focus™/news-articles/2018/1/fda-warns-doctors-of-collapsed-lungs-and-deaths-possibly-linked-to-feeding-tube-placement-devices|Avanos Medical|Cortrak 2 eternal access system|Avanos Medical|Avanos Medical feeding tube|https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas