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There are 60 reported injuries and 23 deaths as a result of this issue.
This recall is classed by FDA as a class I recall. This is the most serious kind. The devices could result in grave injuries, and possibly death.
Sam Brusco, Associate Editor05.16.22
The FDA has confirmed Avanos Medical’s recall of its Cortrak*2 intramuscular accessibility system. Cortrak 2 eternal access system Since March 21st, 2016, 629 devices were recalled in the U.S.
Cortrak*2 lets clinicians insert medical feeding tubes inside the small bowel or stomach of patients who require nutritional assistance.
Avanos Medical feeding tube Avanos Medical feeding tube The device was temporarily recalled due to injury and patient death reports following nasocentric or nasogastric tube misplacement when it is employed to to insert these tubes. Nasogastric, also known as nasoenteric, tube which is not properly placed could result in damage to the vocal chords or trachea. It could result in serious injury, or even death.
According to Avanos' safety communications, there were 60 injuries and 23 deaths related to this incident. The adverse events mentioned included perforation, respiratory failure and pneumonia, in addition to the pleural effusion.
Avanos Medical feeding tube Cortrak*2 has used this recall to update its instructions for usage and intended use. Users will need to verify the location of tubes in accordance with the protocols of institutions before they are able to deliver nutritional supplements.
Clinicians were also advised to attach the amended note in the field on the issue to Avanos' operating manual, and to return the acknowledgement forms that came with Avanos' notice. The company hopes to soon offer users with updated labeling. This includes confirmation that tube placement was carried out in accordance with institutional guidelines.
Avanos Medical Cortrak 2 eternal access system
Here's my 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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