This incident is the cause of at least 60 injuries , and 23 fatalities. Cortrak 2 eternal access system The recall has been classified by FDA as a class I recall. Cortrak 2 eternal access system Avanos Medical feeding tube https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas This is the most serious form of recall. The devices could cause grave injuries, or even death. Avanos Medical Sam Brusco, Associate Editor05.16.22 The FDA has discovered Avanos Medical’s recall of its Cortrak*2 intramuscular access system. The recall of 629 devices distributed between 2016 and 2022 started on the 21st of March. Avanos Medical Cortrak 2 eternal access system Cortrak*2 allows clinicians to place medical feeding tubes in the small bowel or stomach of patients who require nutrition. The system's recall was caused by injuries and deaths of patients due to the incorrect placement of nasocentric/nasogastric tubes. These tubes are used to aid in insertion. An incorrectly placed nasogastric/nasoenteric tube can cause serious injury or death. According to Avanos' safety communication There have been 53 deaths and 60 injuries related to this issue. Adverse events reported included respiratory failure, pneumothorax, perforation, pneumonia and the development of pleural effusion. Cortrak*2 will use this recall to improve the guidelines for use and intended uses. Users will need to confirm the proper placement of tubes in accordance with established protocols before they are able to deliver nutritional supplements. Clinicians were also urged to attach the amended field notice regarding the problem to Avanos' operating manual, and to return the acknowledgement forms included with Avanos announcement. Avanos hopes to give users updated labeling. This will include confirmation that the placement of the tube was performed in accordance with the institution's policies.
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