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There have been 60 injuries and 23 deaths due to this issue.
https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ The FDA has declared this a Class I Recall, which is the most serious kind. Cortrak 2 eternal access system These devices could cause grave injuries, and possibly death.
https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of the Cortrak*2 user access system. Avanos Medical feeding tube The recall of 629 devices that were distributed between 2016 and 2022 started on the 21st of March.
Cortrak*2 is an instrument that permits doctors to introduce medical feeding tubes into patients' stomachs or small bowels.
Avanos Medical This recall was initiated because of reports of injuries and even death among patients after the incorrect placement of gastric or nasocentric tubes. The device is used to insert these tubes. If the tube is not properly placed, it could cause severe injury or even death.
As per Avanos safety communication the problem has led to 60 injuries and 23 deaths. The adverse events reported included pneumonia, perforation, respiratory failure, and pneumonia, in addition to the pleural effusion.
Cortrak*2 will make use of the recall to update its directions for usage and intended usage. It will also instruct users to ensure the tube is placed using institutional protocols before delivering nutritional supplements.
Clinicians were also advised to attach the field-correction notice about the issue to the operating manual and return the acknowledgement forms included in the notice to Avanos. Avanos is hoping to give users with updated labeling. This will include confirmation that tube placement was carried out in accordance with institutional policy.
Here's my website: https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/
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