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This problem has resulted in 60 injuries and 23 deaths.
This recall is classed by FDA as a class I recall. This is the most serious type. Use of these devices may result in serious injuries or even death.
Sam Brusco Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 user access system. 629 devices, which were distributed between 2016 - 2022, were recalls by the U.S. starting on March 21.
Cortrak*2 aids clinicians to place medical feeding tubes in the stomach or in the small bowels of patients needing to receive nutrition via tube.
The recall was caused by reports of death and injuries from patients after nasocentric/nasogastric tube placement error. feeding tube placement This device is used for helping to place the tubes. Avanos Medical Avanos Medical feeding tube If the tube is not properly placed, it can cause serious injury or death.
According to Avanos, there have been a total of 60 injuries and 23 death connected to this problem. https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ There were a variety of adverse events, such as pneumothorax, respiratory failure, perforation as well as pleural effusion and pneumonia.
Cortrak*2 will utilize the recall to revise its directions for usage and intended usage. It will instruct users to ensure the tube is placed with the help of institutional protocols prior to providing nutrition.
Clinicians were also urged to attach the corrected field notice regarding the issue to Avanos' operating manual, and to return the acknowledgment forms that came with Avanos announcement. Avanos hopes to give users updated labeling. Cortrak 2 eternal access system This will include confirmation that the placement of the tube was performed in accordance with the institution's policies.
Website: https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system
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