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This issue is responsible for at the very least 60 injuries and 23 deaths.
The FDA has identified this as a Class I recall, the most serious type of recall. The devices could result in grave injuries, and possibly death.
feeding tube placement Sam Brusco Associate Editor05.16.22
The FDA has confirmed Avanos Medical’s recall for the Cortrak*2 oral access system. Since March 21st, 2016, 629 devices were recalled across the U.S.
Avanos Medical Cortrak 2 eternal access system Cortrak*2 aids clinicians to place medical feed tubes in patients who require nutrition via the tube.
https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 The recall was initiated in response to reports of injuries and deaths in patients due to the incorrect placement of gastric or nasocentric tubes. Avanos Medical The device is used to insert these tubes. feeding tube placement If a nasogastric tube is inserted incorrectly there could be damage to the vocal cords, lungs, or trachea, resulting in serious injury or death.
According to Avanos’ safety communication, there were 60 deaths and 23 injuries resulting from this issue. There were several adverse events, including pneumothorax, respiratory failure, perforation as well as pleural effusion and pneumonia.
Avanos Medical feeding tube The recall is being used to update Cortrak*2's instructions on use and intended use and to instruct users to verify the placement of the tube based on institutional protocols before making use of the tube to provide nutrients.
Clinicians were also asked to attach the correction notice concerning the issue in the operating book and then return the acknowledgement form with the notice to Avanos. The company hopes to soon give users with an updated labeling. This will include confirmation that tube placement was carried out in accordance with institutional policies.
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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