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This problem has resulted in more than 23 deaths and 60 injuries.
The FDA has classified this as an Class I recall, which is the most serious type of recall. These devices could cause serious injuries or even death.
Avanos Medical Avanos Medical Sam Brusco Associate Editor05.16.22
The FDA has discovered Avanos Medical's recall of their Cortrak*2 intramuscular accessibility system. 629 devices, distributed from 2016 and 2022, were recalls by the U.S. starting on March 21.
Cortrak*2 is a device that lets doctors insert medical feeding tubes in patients' stomachs or small bowels.
Avanos Medical feeding tube https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding The recall of the system was caused by patient deaths and injury following the incorrect placement of nasocentric/nasogastric tubes. Avanos Medical https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ These tubes are used to aid in placing them. Incorrectly inserting a nasogastric tube or nasoenteric one can cause serious injury and even cause death.
As per Avanos safety communication the problem has led to sixty injuries and 23 deaths. The adverse events that were reported include pneumothorax, respiratory failure, perforation, pneumonia, as well as the development of pleural effusion.
This recall is utilized to modify Cortrak*2's guidelines for use, intended uses and to instruct users to ensure that the tube is placed as per institutional guidelines prior to using the tube to deliver nutrients.
https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ Clinicians are also advised to attach the field-correction note to the operating guideline and return the acknowledgement form included in the notice to Avanos. The company plans to give users an new labeling and confirmation of the placement of tubes according to institutional policies before use.
Here's my website: https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/
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