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This issue is responsible for at least 60 injuries , and 23 deaths.
The recall is classed by FDA as a class I recall. This is the most serious type. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery These devices can lead to grave injuries, and possibly death.
Sam Brusco Associates Editor05.16.22
The FDA has confirmed Avanos Medical's recall of its Cortrak*2 oral access device. 629 devices, distributed between 2016 and 2022, were recalled by U.S. starting on March 21.
Cortrak*2 assists clinicians in placing medical feeding tubes in the stomachs or small bowels of patients who require to be fed by the tube.
Avanos Medical The recall was triggered by death and injury reports from patients who suffered from nasocentric or nasogastric mistaken placement. This device is utilized for helping to place these tubes. A nasogastric, or nasoenteric, tube that is not correctly inserted can cause damage to the vocal chords or trachea. This can lead to serious injuries, or death.
Avanos Medical As per Avanos safety information the problem has led to 60 injuries and 23 deaths. The adverse events that were mentioned included respiratory failure, perforation, and pneumonia, as well as pleural effusion.
Avanos Medical Cortrak*2 will utilize the recall to update its directions for usage and intended usage. Avanos Mediacal Cortrak 2 It will advise users to verify tube placement with the help of institutional protocols prior to providing nutrition.
Clinicians were advised to add the corrective field notice about the issue in their operating manuals and return the acknowledgement form which was enclosed in the notice to Avanos. Avanos Medical Avanos plans to offer users updated labeling, including confirmation of tube placement in accordance with the institution's policies prior to use.
Avanos Mediacal Cortrak 2 Avanos Medical feeding tube
My Website: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview
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