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This issue is responsible for at least 60 injuries , and 23 deaths.
The FDA has declared this a Class I Recall, which is the most serious type. These devices can cause grave injuries, or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall of their Cortrak*2 intramuscular access system. The recall of 629 devices distributed between 2016-2022 began on the 21st of March.
Avanos Medical feeding tube Cortrak*2 helps clinicians place medical feeding tubes into the stomach or small bowel of patients who require nutrition through the tube.
The system was recalled because of injury and death reports following nasocentric or Nasogastric tube misplacement while it is employed to help place these tubes. https://www.newsbreak.com/news/2607393691988/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i Incorrectly inserting the Nasogastric or Nasoenteric tube can cause serious injuries or even death.
Avanos Medical According to Avanos' safety communication There have been 60 injuries and 23 deaths related to this issue. https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ The adverse events reported included pneumonia, perforation, respiratory failure, and pneumonia, in addition to the pleural effusion.
Avanos Medical Avanos Mediacal Cortrak 2 Cortrak*2 will make use of the recall process to modify its directions for usage and intended uses. Cortrak 2 eternal access system It will also instruct users to verify tube placement by using protocols established by institutions prior to delivering nutritional supplements.
Clinicians were advised to add the corrective field notice regarding the issue to their operating manual and to return the acknowledgement form which was enclosed with the notification to Avanos. The company is expected to be able provide the latest labeling to users, including confirmation of tube placement in accordance with the institutional guidelines.
Here's my website: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm
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