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This has led to more than 23 deaths and 60 injuries.
https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement The FDA has declared this to be an Class I recall, the most severe type of recall. These devices can cause serious injuries or even death.
https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system Sam Brusco Associate Editor05.16.22
The FDA has identified Avanos Medical's recall for the Cortrak*2 oral access system. 629 devices, distributed from 2016 - 2022, were recalled by the U.S. starting on March 21.
Cortrak*2 allows clinicians to place medical feeding tubes inside the stomach or small bowel of patients who require nutritional assistance.
https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ The recall was caused by injury and death reports from patients who suffered from nasocentric or nasogastric misplacement. Cortrak 2 eternal access system Avanos Medical The device is used for helping to place these tubes. A wrongly placed nasogastric or nasal tube could cause severe injury or death.
Avanos Medical According to Avanos' safety communication, there have been sixty-three injuries and 23 deaths related to this issue. Adverse events reported included respiratory failure, pneumothorax, perforation, pneumonia and pleural effusion.
Avanos Mediacal Cortrak 2 Cortrak*2 is using the recall process to make revisions to its guidelines to use. The updated instructions will contain instructions for users to verify that tubes are placed in accordance with institutional protocols prior to applying them to provide nutrition.
Avanos Medical feeding tube Clinicians were also encouraged to add the updated field notice regarding the problem to Avanos operating manual and to return the acknowledgement forms in Avanos' announcement. The company aims to soon provide users with updated labeling, including confirmation of tube placement as per the policies of the institution prior to use.
Avanos Medical
Read More: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm
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