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This problem has caused 60 injuries and 23 deaths.
The FDA has classified this as a Class I Recall, the most serious kind. These devices could lead to grave injuries, or even death.
Avanos Medical Sam Brusco Associate Editor05.16.22
The FDA has confirmed Avanos Medical’s recall for its Cortrak*2 oral access system. The recall of 629 devices distributed between 2016-2022 began on March 21.
Cortrak*2 assists clinicians in placing medical feeding tubes into the stomachs or small bowels of patients who need to be fed through the tube.
Cortrak 2 eternal access system The recall of the system was caused by the deaths and injuries of patients resulting from the incorrect placement of nasocentric/nasogastric tubes. Avanos Medical These tubes are used to aid in placing them. Incorrectly inserting a nasogastric tube or nasoenteric one can cause serious injury or even death.
According to Avanos' safety communications, there were 60 injuries and 23 deaths related to this incident. Avanos Medical https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding The adverse events that were reported included pneumonia, respiratory failure, perforation, and pneumonia, as well as the pleural effusion.
Cortrak 2 eternal access system Avanos Medical feeding tube The recall is used to modify Cortrak*2's directions for use and intended uses and instructing users to confirm the placement of the tube based on guidelines for institutions prior to using the tube to deliver nutrition.
Clinicians were also encouraged to add the updated field notice on the issue to Avanos operating manual and to return the acknowledgement forms included with Avanos' notice. Avanos plans to provide users with new labeling and confirmation of tube placement as per the policies of the institution prior to the use.
My Website: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its
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