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This has resulted in 60 injuries and 23 deaths.
This recall was identified by the FDA as classified as a Class I recall. It is the most serious type of recall. The devices could cause serious injuries, and even death.
Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical as the company responsible for recalling its Cortrak*2 system for enteral access. 629 devices, distributed from 2016 - 2022, were recalled by the U.S. starting on March 21.
Cortrak*2 allows clinicians to place medical feeding tubes into the small bowel or stomach of patients that require nutrition.
The recall was triggered by injury and death reports from patients after nasocentric/nasogastric tube placement error. The device is used for helping to place these tubes. feeding tube placement If a nasogastric, or nasoenteric tube is incorrectly inserted, damage can occur to the vocal cords, lungs, or trachea, which can result in severe injury or death.
Cortrak 2 eternal access system According to Avanos Safety communications, there were 60 injuries and 23 deaths attributed to this incident. https://www.aboutlawsuits.com/feeding-tube-system-deaths-138564/ Pneumothorax (perforation), pneumothorax (perforation) and pneumonia and pleural effusion were all reported as adverse events.
Cortrak*2 has used this recall to update the instructions for its usage and intended use. Avanos Medical Users will need to confirm the proper placement of tubes based on institutional protocols, before they are able to deliver nutritional supplements.
Clinicians were required to attach the correction notice regarding the issue to the operating book and then return the acknowledgement form along with the notification to Avanos. Avanos Medical feeding tube The users will shortly receive an update to the labels and confirmation that tubes were placed in accordance with the institution's policies.
Website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement
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