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This problem has caused 60 injuries, and 23 deaths.
The recall was classified by the FDA as a Class I recall. It is the most serious type of recall. These devices could cause serious injury or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has discovered Avanos Medical’s recall of their Cortrak*2 intramuscular accessibility system. The recall of 629 devices distributed between 2016-2022 began on the 21st of March.
Cortrak*2 aids clinicians when placing medical feeding tubes inside the stomach or small bowels of patients who require to be fed via the tube.
The recall was triggered by death and injury reports of patients suffering from nasocentric/nasogastric tube misplacement. This device is utilized to assist in placing the tubes. Nasogastric, also known as nasal, tube that isn't properly inserted could result in damage to the vocal chords or trachea. Avanos Mediacal Cortrak 2 feeding tube placement This could lead to serious injury, or even death.
Avanos Medical feeding tube According to Avanos’ safety communication, there were 60 deaths and 23 injuries that were related to this problem. Avanos Medical feeding tube Adverse events reported included pneumothorax, respiratory failure, perforation, pneumonia and pleural effusion.
This recall is used to revise Cortrak*2's instructions regarding use, intended usage and to remind users to confirm tube placement in accordance with institutional guidelines prior to using the tube in order to provide nutritional benefits.
http://ezproxy.cityu.edu.hk/login?url=https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Clinicians were urged to attach the corrective field note concerning the issue to their operating manuals and return the acknowledgement form which was enclosed in the notice to Avanos. The company is planning to provide users with current labels, as well as confirmation of tube placement in accordance with the institutional guidelines.
Here's my website: https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html
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