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This issue has caused 60 injuries and 23 deaths.
Avanos Medical feeding tube Avanos Medical https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/ This is an item classified as a Class I recall by FDA, which is the most severe type. These devices could cause severe injuries or even death.
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 Sam Brusco Associate Editor05.16.22
The FDA has confirmed the recall by Avanos Medical of its Cortrak*2 entry access system. The recall of 629 devices distributed from 2016 to 2022 began on the 21st of March.
Cortrak*2 assists clinicians in placing medical feeding tubes in the stomach or in the small bowel of patients needing to receive nutrition through the tube.
The recall was initiated in response to reports of injuries and even death among patients after mistakes in the placement of gastric or nasocentric tubes. The device is used to insert the tubes. When you are not careful, inserting a nasogastric tube or nasoenteric tube can result in serious injury or even death.
https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical According to Avanos the safety announcement the company has reported 53 deaths and 60 injuries related to this issue. Pneumothorax and pneumothorax (perforation) and pneumonia and pleural effusion have all been identified as adverse events.
Avanos Medical Cortrak*2 will use this recall to update its instructions for usage and intended use. Avanos Medical feeding tube Users must confirm the placement of tubes based on the protocols of institutions before they can deliver nutrition.
Clinicians were also urged to add the updated field notice regarding the problem to Avanos operating manual and return the acknowledgement forms in Avanos' notice. The company is expected to be able to send out updated labeling to users, including confirmation of tube placement according to the policies of the institution.
My Website: https://www.aboutlawsuits.com/feeding-tube-system-deaths-138564/
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