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This problem has resulted in more than 23 deaths and 60 injuries.
This is a Class I recall by FDA which is the most serious type. These devices can cause serious injuries and even death.
Sam Brusco Associates Editor05.16.22
The FDA has discovered Avanos Medical's recall of their Cortrak*2 intramuscular accessibility system. 629 of the devices produced between 2016 until 2022 were recalls, with the first recall happening on March 21.
Cortrak*2 is a device that permits doctors to place medical feeding tubes inside patients stomachs, or small bowels.
This recall was initiated in response to reports of injuries and deaths in patients due to mistakes in the placement of gastric or nasocentric tubes. The device is used to place these tubes. A nasogastric, or nasoenteric, tube which is not properly placed could result in damage to the vocal chords and trachea. This can lead to serious injury, or even death.
According to Avanos Safety Communication the company has reported 60 injuries and 23 deaths connected to this incident. Many adverse events were reported, including respiratory failure, pneumonia, and pneumothorax.
Cortrak*2 will use this recall to improve its instructions for usage and intended use. feeding tube placement Users must confirm the placement of the tubes according to the protocols of institutions before they are able to deliver nutritional supplements.
Clinicians were directed to attach the relevant field correction notice to their operating manual. They should also return the acknowledgement slip included with the Avanos notice. Avanos Medical feeding tube Cortrak 2 eternal access system The users will shortly receive an update to the labels and confirmation that tubes were placed according to institution guidelines.
Avanos Medical
Read More: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical
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