The issue has caused at the very least 60 injuries and 23 fatalities. This recall has been classified by FDA as a class I recall. This is the most serious kind. These devices could cause serious injuries, or even death. Sam Brusco Associates Editor05.16.22 The FDA has identified Avanos Medical's recall of its Cortrak*2 access system for enteral use. The recall of 629 devices distributed from 2016 to 2022 began on March 21. Cortrak 2 eternal access system Cortrak*2 aids clinicians when placing medical feeding tubes into the stomachs or small bowels of patients who require to be fed through the tube. Avanos Medical Due to the possibility of injuries or deaths, the system was recalled. Nasogastric, also known as nasal, tube which is not properly placed can cause damage to the vocal chords or the trachea. Avanos Medical feeding tube Avanos Medical This can lead to severe injury or death. According to Avanos, there have been an estimated sixty injuries and 23 deaths related to this issue. Numerous adverse events were identified, including respiratory failure, pneumonia, and pneumothorax. Cortrak*2 has utilized the recall to make updates to its procedures for its use. The updated instructions will include instruction to users to ensure that the tubes are set up according to institutional protocols prior to making use of them to deliver food. Avanos Medical feeding tube Clinicians were required to attach the notice of correction regarding the issue to the operating book and return acknowledgment forms along with the notice to Avanos. Avanos Medical Avanos is hoping to offer users with updated labels. This includes confirmation that tube placement was done according to institutional policy.
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