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This issue has led to 60 injuries, and 23 deaths.
Avanos Mediacal Cortrak 2 The recall was classified by the FDA as classified as a Class I recall. Cortrak 2 eternal access system It is the most serious type of recall. These devices can cause serious injuries, or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has discovered the recall by Avanos Medical of its Cortrak*2 entry access system. 629 devices, which were distributed between 2016 - 2022, were recalled by U.S. starting on March 21.
Cortrak*2 permits clinicians to insert medical feeding tubes inside the stomach or small bowel of patients that require nutritional assistance.
Due to the possibility of injuries or deaths, the system was recalled. If a nasogastric, or nasoenteric tube is incorrectly inserted, damage can occur to the vocal cords, lungs, or trachea, which can result in severe injury or death.
According to Avanos the safety announcement the company has reported sixty-three injuries and 23 deaths in connection with this incident. Avanos Mediacal Cortrak 2 Pneumothorax (perforation), pneumothorax (perforation) pneumonia, and pleural effusion were all reported as adverse events.
Cortrak*2 has utilized the recall to make changes to its guidelines for its use. feeding tube placement The updated instructions will contain instructions for users to make sure that tubes are placed in accordance with the guidelines of the institution before applying them to provide nutrition.
https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ Clinicians were requested to attach the correct notice regarding the issue in the operating book and then return acknowledgment forms along with the notification to Avanos. Avanos Medical The users will shortly receive an update to the labels and confirmation that tubes were placed in accordance with institution guidelines.
https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its
Read More: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding
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