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This issue has led to 60 injuries, and 23 deaths.
The FDA has identified this as an Class I recall, which is the most serious kind of recall. These devices could cause serious injuries, or even death.
https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system of enteral access. 629 devices, distributed between 2016 and 2022, were recalled by U.S. starting on March 21.
Cortrak*2 aids clinicians to place medical feed tubes into patients that require nutrition via the tube.
https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ This recall was prompted because of reports of injuries and even death among patients after the incorrect placement of gastric or nasocentric tubes. Cortrak 2 eternal access system The device is used to position these tubes. If a nasogastric or nasoenteric tube is incorrectly inserted it can cause damage to the vocal cords, lungs or trachea, resulting in serious injury or death.
According to Avanos' safety communications there were 60 injuries and 23 fatalities related to this incident. There have been several adverse events, including pneumothorax, respiratory failure, perforation as well as pleural effusion and pneumonia.
Avanos Medical feeding tube Avanos Medical feeding tube This recall is used to update Cortrak*2’s instructions regarding use, intended usage and also advise users to confirm tube placement as per institutional guidelines prior to making use of the tube to supply nutrition.
Clinicians are also advised to attach the field-correction notice to the operating manual and return the acknowledgement form that was included in the notice to Avanos. The company will soon be able to provide updated labeling for users, which will include confirmation of tube placement in accordance with the institutional guidelines.
Read More: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding
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