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This is the reason for the deaths of 60 people and 23 injuries.
The FDA has classified this as a Class I Recall, the most severe type. These devices could lead to serious injuries or even death.
Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 intramuscular access system. 629 devices that were distributed between 2016 and 2022 were recalled within the U.S., beginning on the 21st of March.
Cortrak*2 assists clinicians in placing medical feeding tubes inside the stomach or small bowels of patients that need to be fed via the tube.
The system's recall was due to patient deaths and injury following an error in placement of the nasocentric or nasogas. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system These tubes aid in insertion. Cortrak 2 eternal access system When you are not careful, inserting a nasogastric tube or nasoenteric can result in grave injury or even death.
According to Avanos safety information the issue has resulted in more than 23 deaths and 60 injuries. Pneumothorax and pneumothorax (perforation), pneumonia, and pleural effusion were all listed as adverse events.
Cortrak*2 has used the recall to make updates to its instructions to use. Cortrak 2 eternal access system The updated instructions will contain instructions for users to verify that tubes are placed in accordance with the guidelines of the institution before applying them to provide nutrition.
Avanos Medical Clinicians were urged to attach the corrective field note concerning the issue to their operating manuals and return the acknowledgement form that was enclosed with the notification to Avanos. Avanos plans to provide users with current labeling and also a confirmation of tube placement in accordance with the institutional guidelines.
Avanos Medical feeding tube
Website: https://www.productsafety.gov.au/recalls/avanos-medical-australia-pty-ltd-%E2%80%94-mic-gastrostomy-feeding-tubes-expanded-recall
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