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This issue has led to sixty injuries and 23 deaths.
This recall is classified by FDA as a class I recall. This is the most serious form of recall. https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54 These devices could lead to grave injuries, or even death.
Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical's recall of the Cortrak*2 user access system. 629 devices made between 2016 to 2022 were recalled with the first recall occurring on the 21st of March.
Avanos Medical Cortrak*2 helps clinicians place medical feeding tubes into the stomach or in the small bowels of patients needing to receive nutrition via the tube.
Cortrak 2 eternal access system The recall was triggered by injury and death reports from patients who suffered from nasocentric or nasogastric misplacement. This device is used for helping to place the tubes. When you are not careful, inserting a nasogastric tube or nasoenteric can result in serious injury and even cause death.
Avanos Medical According to Avanos reports, there were more than 60 injuries and 23 death related to this issue. A variety of adverse events were identified which included respiratory failure, pneumonia, and pneumothorax.
Cortrak*2 will use this recall to update the guidelines for use and intended uses. Users must confirm the proper placement of tubes in accordance with the protocols of institutions before they can be used to provide nutrition.
Clinicians were advised to add the corrective field notice about the issue in their operating manuals and return the acknowledgement form that was included with the notice to Avanos. Cortrak 2 eternal access system The company hopes to soon offer users updated labeling. Avanos Medical Avanos Medical feeding tube This includes confirmation that tube placement was performed in accordance with the institution's policies.
Avanos Medical
Homepage: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/
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