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This issue has led to sixty injuries and 23 deaths.
Avanos Medical feeding tube Avanos Medical The recall is classed by FDA as a class I recall. This is the most serious type. These devices could lead to serious injuries or even death.
Avanos Medical Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 access device for use in the system. The recall of 629 devices that were distributed between 2016 and 2022 started on March 21.
Cortrak*2 permits clinicians to insert medical feeding tubes inside the small bowel or stomach of patients that require nutritional assistance.
The recall of the system was caused by the deaths and injuries of patients resulting from the incorrect placement of nasocentric/nasogastric tubes. These tubes aid in insertion. Avanos Medical A nasogastric, or the nasoenteric tube, which is not properly placed could result in damage to the vocal cords or the trachea. This could lead to severe injury or death.
According to Avanos, there have been a total of sixty injuries and 23 deaths related to this issue. Numerous adverse events were identified such as respiratory failure, pneumonia, and pneumothorax.
The recall is being leveraged to revise Cortrak*2's guidelines regarding use and intended usage and to instruct users to verify tube placement based on protocol guidelines before making use of the tube to deliver nutrients.
Avanos Medical Clinicians were instructed to attach the pertinent field correction notice to the operating manual. They should also return the acknowledgement slip that came along with the Avanos notification. Cortrak 2 eternal access system Users will soon receive updated labels and confirmation that tubes were placed in accordance with the institution's policies.
Read More: https://journals.lww.com/biomedicalsafetystandards/Citation/2022/07150/Avanos_Medical_Cortrak2_Enteral_Access_System.2.aspx
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