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This has resulted in 60 injuries and 23 deaths.
The FDA has declared this to be a Class I recall, which is the most serious type of recall. Avanos Medical feeding tube These devices can cause serious injuries, or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the company responsible for recalling its Cortrak*2 system of enteral access. Cortrak 2 eternal access system The recall of 629 devices distributed from 2016 to 2022 began on the 21st of March.
Avanos Medical Cortrak*2 is an instrument that permits doctors to insert medical feeding tubes in patients stomachs or small bowels.
The recall of the system was caused by the deaths and injuries of patients resulting from misplacement of nasocentric/nasogastric tubes. These tubes are used to aid in the placement of them. A wrongly placed nasogastric or nasal tube could cause severe injury or death.
According to Avanos' safety communication, there have been sixty-three injuries and 23 deaths connected to this incident. There have been several adverse events, including pneumothorax, respiratory failure, perforation, pneumonia and pleural effusion.
Cortrak*2 will make use of the recall to revise its instructions for usage and intended uses. It will instruct users to ensure the tube is placed by using protocols established by institutions prior to delivering nutrition.
Clinicians were instructed to add the pertinent field correction notice in the operating manual. https://avanos.com/investor-news/response-to-inquiries-about-the-avanos-cortrak-2-voluntary-field-correction/ They must also return the acknowledgement slip included along with the Avanos notice. Cortrak 2 eternal access system https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ Users will soon receive updated labels and confirmation that tubes were placed in accordance with institution guidelines.
Website: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/
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