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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
There have been 60 injuries and 23 deaths related to this issue.

The FDA has declared this to be a Class I recall, the most serious type of recall. These devices can cause serious injuries, or even death.

https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Sam Brusco, Associate Editor05.16.22

The FDA has confirmed Avanos Medical’s recall for its Cortrak*2 oral access system. 629 devices made between 2016 to 2022 were recalled with the first recall happening on March 21.

Cortrak*2 assists clinicians in placing medical feeding tubes into the stomach or small bowels of patients who need to be fed via the tube.

The recall was initiated in response to reports of injuries and death in patients following misplacement of nasocentric or gastric tubes. The device is used to insert these tubes. Cortrak 2 eternal access system A mistake in the placement of an Nasogastric tube or Nasoenteric one can cause serious injuries or even death.

According to Avanos' safety communications there were 60 injuries and 23 fatalities related to this issue. Cortrak 2 eternal access system Avanos Medical The adverse events mentioned included perforation, respiratory failure and pneumonia, in addition to the pleural effusion.

Cortrak*2 has utilized the recall process to make revisions to its procedures for use. The updated guidelines will contain instructions for users to make sure that tubes are placed in accordance with the guidelines of the institution before applying them to provide nutrition.

Clinicians were also advised to attach the field-correction notice about the issue to the operating manual and return the acknowledgement form that was included with the notification to Avanos. The users will shortly receive an update to the labeling and confirmation that the tubes were placed in accordance with institution policy.


Homepage: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm
     
 
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