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This incident is the cause of at least 60 injuries , and 23 deaths.
The recall has been classified by FDA as a class I recall. This is the most serious form of recall. These devices could cause serious injuries, or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall of their Cortrak*2 intramuscular accessibility system. Avanos Medical feeding tube Cortrak 2 eternal access system Beginning on March 21 the 21st of March, 2016, 629 devices were recalled in the U.S.
Cortrak*2 lets clinicians insert medical feeding tubes inside the stomach or small bowel of patients that require nutrition.
The recall was initiated because of reports of injuries and death in patients following misplacement of nasocentric or gastric tubes. The device is used to position the tubes. Nasogastric, also known as nasal, tube that isn't properly inserted could result in damage to the vocal chords and trachea. feeding tube placement This could lead to severe injury or death.
According to Avanos reports, there were more than 60 injuries and 23 deaths in connection with this issue. Numerous adverse events were identified, including respiratory failure, pneumonia and pneumothorax.
Cortrak*2 will utilize the recall to update its instructions for usage and intended use. feeding tube placement It will instruct users to check the placement of tubes with the help of institutional protocols prior to providing nutritional supplements.
Avanos Mediacal Cortrak 2 Clinicians were also asked to attach the correction notice about the problem to the operating book and return the acknowledgement form with the notification to Avanos. Avanos is hoping to provide users with updated labeling. This will include confirmation that tube placement was done according to institutional policy.
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