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There were 60 injuries as well as 23 deaths as a result of this problem.
The FDA has declared this to be an Class I recall, which is the most serious type of recall. Avanos Medical feeding tube These devices could lead to severe injuries or even death.
https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical’s recall its Cortrak*2 access device for use in the system. 629 devices made between 2016 to 2022 were recalled with the first recall occurring on the 21st of March.
Cortrak*2 lets clinicians insert medical feeding tubes in the small bowel or stomach of patients who require nutritional assistance.
The recall was triggered by death and injury reports from patients after nasocentric/nasogastric tube misplacement. The device is used to assist in placing the tubes. Avanos Medical https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ If a nasogastric, or nasoenteric tube is incorrectly inserted it can cause damage to the vocal cords, lungs, or trachea, which can result in serious injury or death.
According to Avanos reports, there were an estimated 60 injuries and 23 death in connection with this issue. Some of the adverse events reported were pneumothorax, respiratory failure perforation, pneumonia, and pleural effusion.
Cortrak*2 will make use of the recall to revise its guidelines for use and intended usage. It will instruct users to ensure the tube is placed with the help of institutional protocols prior to providing nutritional supplements.
Clinicians were required to attach the correct notice concerning the issue to the operating book, and return the acknowledgement form with the note to Avanos. Avanos Medical Avanos Medical feeding tube The company will soon be able to provide updated labeling to users, including confirmation of the placement of tubes in accordance with the institutional guidelines.
Avanos Medical
My Website: https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns
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