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There have been 60 injuries and 23 deaths due to this problem.
This is an item classified as a Class I recall issued by FDA which is the most serious kind. These devices can cause serious injuries, and even death.
Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 intramuscular accessibility system. The recall of 629 devices that were distributed between 2016 and 2022 started on the 21st of March.
feeding tube placement Cortrak 2 eternal access system Cortrak*2 lets clinicians insert medical feeding tubes in the small bowel or stomach of patients who require nutritional assistance.
The system's recall was caused by injuries and deaths of patients due to misplacement of nasocentric/nasogastric tubes. These tubes aid in placing them. A mistake in the placement of a Nasogastric or Nasoenteric tube could cause severe injuries or even death.
According to Avanos' safety communications the number of injuries was 60 and 23 deaths attributed to this issue. A variety of adverse events were reported, including respiratory failure, pneumonia, and pneumothorax.
This recall will be used to update Cortrak*2’s instructions regarding use, intended usage and also remind users to ensure that the tube is placed according to institutional protocols before making use of the tube to provide nutritional benefits.
https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical Clinicians were advised to add the corrective field notice regarding the issue to their operating manual and return the acknowledgement form which was enclosed with the notice to Avanos. Avanos Medical feeding tube The company is planning to provide users with current labels, along with confirmation of placement of tubes according to the policies of the institution.
Website: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
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