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This issue has caused the deaths of 23 people and 60 injuries.
The FDA has classified this as a Class I Recall, the most serious kind. Avanos Medical These devices can cause serious injuries and even death.
Sam Brusco is Associate Editor05.16.22
The FDA has identified Avanos Medical’s recall its Cortrak*2 useal access system. 629 devices, which were distributed between 2016 - 2022, were recalls by the U.S. starting on March 21.
feeding tube placement Cortrak*2 aids clinicians to place medical feeding tubes in the stomach or small bowel of patients needing to receive nutrition via the tube.
Avanos Medical The recall of the system was due to injuries and deaths of patients due to an error in placement of the nasocentric or nasogas. These tubes are used to aid in the placement of them. An incorrectly placed nasogastric/nasoenteric tube can cause serious injuries or even death.
According to Avanos’ safety communication the number of deaths was 60 and 23 injuries resulting from this problem. Numerous adverse events were reported which included pneumonia, respiratory failure and pneumothorax.
feeding tube placement Cortrak*2 will utilize the recall to update its instructions for usage and intended usage. It will also instruct users to check the placement of tubes by using protocols established by institutions prior to delivering nutritional supplements.
Clinicians are also advised to attach the field correction note to the operating manual , and return the acknowledgement form that was included in the notice to Avanos. Avanos hopes to provide users with updated labeling. Avanos Medical https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ This will include confirmation that the placement of the tube was done according to institutional policies.
Website: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding
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