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There are 60 reported injuries and 23 deaths as a result of this problem.
https://journals.lww.com/biomedicalsafetystandards/Citation/2022/08150/Avanos_Cortrak_2_Enteral_Access_System.17.aspx This recall was identified by the FDA as an Class I recall. feeding tube placement Avanos Medical feeding tube It is the most severe form of recall. These devices can lead to serious injuries and even death.
Sam Brusco Associate Editor05.16.22
The FDA has identified Avanos Medical as the company responsible for recalling its Cortrak*2 system for enteral access. 629 devices, which were distributed between 2016 and 2022, were recalled by U.S. starting on March 21.
https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system Cortrak*2 is a tool that lets doctors place medical feeding tubes inside patients stomachs, or small bowels.
In the wake of deaths and injuries, the system was recalled. If a nasogastric, or nasoenteric tube is inserted incorrectly, damage can occur to the vocal cords, lungs, or the trachea, leading to serious injury or death.
According to Avanos the safety announcement the company has reported 53 deaths and 60 injuries connected to this incident. There have been several adverse events, such as pneumothorax, respiratory failure and perforation as well as pleural effusion and pneumonia.
https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ Cortrak*2 has used this recall to revise the instructions for its the use and intended usage. The users will have to verify the location of tubes based on institutional protocols, before they can deliver nutrition.
Cortrak 2 eternal access system Clinicians were also asked to attach the notice of correction regarding the issue to the operating book and then return acknowledgment forms along with the note to Avanos. Avanos plans to give users an current labeling, which will include confirmation of the placement of tubes in accordance with the institution's policies prior to the use.
Avanos Mediacal Cortrak 2
Homepage: https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/
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