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This incident is the cause of at least 60 injuries and 23 fatalities.
This is an item classified as a Class I recall issued by FDA that is the most severe type. These devices can cause serious injuries or even death.
Avanos Medical feeding tube Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system for enteral access. 629 devices, distributed between 2016 and 2022 were recalls by the U.S. starting on March 21.
Avanos Medical feeding tube https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement Cortrak*2 aids clinicians to place medical feeding tubes into the stomach or small bowel of patients who require nutrition via tube.
feeding tube placement The recall was initiated due to reports of injury and even death among patients after misplacement of nasocentric or gastric tubes. 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 The device is used to position the tubes. A mistake in the placement of the Nasogastric or Nasoenteric tube could cause severe injury or death.
Avanos Mediacal Cortrak 2 According to AvanosSafety Communication the number of deaths was 60 and 23 injuries related to the issue. Avanos Mediacal Cortrak 2 There were several adverse events, such as respiratory failure, pneumothorax and perforation, pneumonia and pleural effusion.
feeding tube placement Cortrak*2 will use the recall to revise its guidelines for use and intended uses. It will advise users to ensure the tube is placed using institutional protocols before delivering nutrition.
Cortrak 2 eternal access system Clinicians were also advised to attach the field correction notice about the issue to the operating guideline and return the acknowledgement form that was included with the notice to Avanos. Users will soon receive updated labeling and confirmation that the tubes were placed in accordance with institution policies.
Homepage: https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges
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