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This issue has caused more than 23 deaths and 60 injuries.
The recall was classified by the FDA as classified as a Class I recall. It is the most serious type of recall. The devices could cause serious injuries or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 intramuscular access system. 629 devices manufactured between 2016 until 2022 were recalls, the first recall taking place on the 21st of March.
Cortrak*2 assists clinicians in placing medical feeding tubes inside the stomach or in the small bowel of patients who require nutrition via the tube.
The recall was brought on by reports of death and injuries from patients who suffered from nasocentric or nasogastric misplacement. This device is utilized to assist in placing these tubes. Nasogastric, also known as nasal, tube that is not correctly inserted could cause injury to the vocal cords or the trachea. https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ It could result in severe injury or death.
Avanos Medical According to AvanosSafety Communication, there were 60 deaths and 23 injuries that were related to this problem. Pneumothorax (perforation), pneumothorax (perforation) pneumonia, and pleural effusion were all identified as adverse events.
Cortrak*2 will use the recall to revise its guidelines for use and intended use. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Avanos Medical feeding tube It will advise users to check the placement of tubes with the help of institutional protocols prior to providing food.
Avanos Medical feeding tube Clinicians were instructed to attach the pertinent field correction notice in the operating manual. They must also return the acknowledgement sheet included with the Avanos note. The company is expected to be able provide the latest labeling to users, including confirmation of the placement of tubes according to the policies of the institution.
Avanos Medical
Read More: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
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