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This problem has been the cause for the deaths of 60 and 23 injuries.
The FDA has classified this as an Class I Recall, the most serious kind. These devices can cause serious injury or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the one responsible for recalling its Cortrak*2 system for enteral access. Since March 21st in 2016, 629 of the devices were recalled in the U.S.
Cortrak*2 permits clinicians to insert medical feeding tubes in the stomach or small bowel of patients that require nutrition.
The system's recall was due to the deaths and injuries of patients resulting from an error in placement of the nasocentric or nasogas. Cortrak 2 eternal access system These tubes are used to aid in placing them. Avanos Medical feeding tube Incorrectly inserting a Nasogastric or Nasoenteric tube could cause severe injuries or even death.
According to AvanosSafety Communication the number of deaths was 60 and 23 injuries that were related to the issue. Cortrak 2 eternal access system There were several adverse events, such as respiratory failure, pneumothorax and perforation, pneumonia and pleural effusion.
Cortrak 2 eternal access system Cortrak*2 has used the recall process to make revisions to its instructions to use. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview The updated guidelines will contain instructions for users to ensure that the tubes are placed in accordance with institutional protocols prior to making use of them to deliver food.
Cortrak 2 eternal access system https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/ Clinicians were requested to attach the correct notice concerning the issue to the operating book and return the acknowledgement form along with the notice to Avanos. The company is expected to be able provide the latest labeling for users, which will include confirmation of the placement of tubes in accordance with the institutional guidelines.
Avanos Medical feeding tube
Read More: https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/
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