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This issue has been responsible for the deaths of 60 and 23 injuries.
The FDA has classified this as an Class I Recall, which is the most severe type. These devices can cause serious injuries, or even death.
Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical's recall of their Cortrak*2 intramuscular access system. 629 devices manufactured between 2016 to 2022 were recalled in the U.S., beginning on the 21st of March.
Cortrak*2 aids clinicians to place medical feeding tubes into the stomach or in the small bowel of patients needing to receive nutrition via tube.
The recall was caused by reports of death and injuries from patients who suffered from nasocentric or nasogastric mistaken placement. https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ This device is utilized to aid in the placement of the tubes. Avanos Medical feeding tube When you are not careful, inserting a nasogastric tube or nasoenteric tube can result in grave injury and even cause death.
Avanos Medical https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement According to Avanos the number of incidents has been a total of 60 injuries and 23 death related to this issue. Some of the adverse events reported were pneumothorax, respiratory failure, perforation, pneumonia, and the development of pleural effusion.
The recall is being used to update Cortrak*2's instructions regarding use and intended usage and to instruct users to verify the placement of the tube according to institutional protocols before using the tube to distribute nutrients.
Avanos Medical Clinicians were also advised to attach the field correction notice to the operating manual and return the acknowledgement form that was included with the notification to Avanos. The company hopes to soon provide users with an updated labeling. This includes confirmation that tube placement was carried out in accordance with institutional policy.
Read More: https://aacnjournals.org/ajcconline/article/29/1/22/30624/Pneumothoraces-Prevented-With-Use-of
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