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This incident is the cause of at least 60 injuries and 23 deaths.
https://www.click4r.com/posts/g/4395352/fda-classifies-avanos-medicaland-8217-s-cortrak-2-eas-recall-as-class-i Avanos Mediacal Cortrak 2 The recall is classed by FDA as a class I recall. This is the most serious type. The devices could result in serious injuries and even death.
https://avanosmedicalelur364.wordpress.com/2022/05/24/avanos-medical-recalls-cortrak2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm/ Sam Brusco Associate Editor05.16.22
The FDA has identified Avanos Medical’s recall its Cortrak*2 useal access system. The recall of 629 devices that were distributed between 2016-2022 began on the 21st of March.
Cortrak*2 assists clinicians in placing medical feed tubes into patients who require nutrition via the tube.
In the wake of deaths and injuries due to injuries and deaths, the system was recall. A mistake in the placement of a Nasogastric or Nasoenteric tube could result in severe injury or even death.
According to Avanos the number of incidents has been more than 60 injuries and 23 deaths related to this issue. Avanos Mediacal Cortrak 2 Pneumothorax, pneumothorax (perforation) pneumonia, and pleural effusion have all been identified as adverse events.
Cortrak*2 will use the recall to revise its instructions for usage and intended usage. It will advise users to check the placement of tubes by using protocols established by institutions prior to delivering nutrition.
Clinicians were advised to attach the corrective field note about the issue in their operating manual and to return the acknowledgement form which was enclosed with the notice to Avanos. The company is expected to be able provide the latest labeling for users, which will include confirmation of the placement of tubes according to the policies of the institution.
Avanos Medical
Website: https://avanosmedicalelur364.wordpress.com/2022/05/24/avanos-medical-recalls-cortrak2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm/
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