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This incident is the cause of at least 60 injuries , and 23 fatalities.
https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 The FDA has declared this to be an Class I recall, which is the most serious type of recall. These devices can cause serious injuries or even death.
Avanos Medical feeding tube Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical’s recall for its Cortrak*2 oral access device. Since March 21st the 21st of March, 2016, 629 devices were recalled across the U.S.
Cortrak*2 aids clinicians to place medical feeding tubes in the stomach or small bowel of patients needing to receive nutrition via the tube.
The device was temporarily recalled because of injury and death reports resulting from nasocentric and nasogastric tube misplacement when it is employed to to insert these tubes. Cortrak 2 eternal access system An incorrectly placed nasogastric/nasoenteric tube can result in severe injury or death.
Cortrak 2 eternal access system According to Avanos, there have been an estimated sixty injuries and 23 deaths related to this issue. Avanos Medical Some of the adverse events reported were respiratory failure, pneumothorax, perforation, pneumonia, and pleural effusion.
Cortrak*2 has used the recall to make changes to its instructions for use. The updated guidelines will include instruction to users to make sure that tubes are placed in accordance with institution protocols before making use of them to deliver food.
Clinicians are also advised to attach the field correction notice about the issue to the operating guideline and return the acknowledgement form that was included with the notification to Avanos. https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ Avanos Medical Avanos will shortly be able to provide updated labeling to users, including confirmation of the tube's placement according to the policies of the institution.
Homepage: https://prais.paho.org/es/avanos-medical-recalls-cortrak2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm/
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