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The issue has caused at the very least 60 injuries and 23 deaths.
Avanos Medical This is an item classified as a Class I recall by FDA, which is the most severe type. These devices could lead to severe injuries or even death.
Sam Brusco is Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of the Cortrak*2 access device for use in the system. 629 devices, distributed from 2016 and 2022 were recalled by U.S. starting on March 21.
Cortrak*2 helps clinicians place medical feed tubes on patients that require nutrition via the tube.
This recall was initiated due to reports of injury and deaths in patients due to the incorrect placement of gastric or nasocentric tubes. The device is used to insert the tubes. If the tube is not properly placed, it can cause serious injury or even death.
According to Avanos' safety communications the number of injuries was 60 and 23 fatalities related to this incident. Numerous adverse events were identified, including respiratory failure, pneumonia, and pneumothorax.
Avanos Mediacal Cortrak 2 Avanos Mediacal Cortrak 2 This recall is used to update Cortrak*2’s instructions on use, intended use and to advise users to ensure that the tube is placed according to institutional protocols before making use of the tube to supply nutritional benefits.
Clinicians were requested to attach the correction notice concerning the issue in the operating book and then return the acknowledgement form along with the notification to Avanos. Avanos Medical feeding tube feeding tube placement The users will shortly receive an update to the labels and confirmation that the tubes were placed in accordance with the institution's policy.
My Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
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