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This problem has been the cause for 60 deaths and 23 injuries.
The FDA has classified this as a Class I recall, which is the most serious type of recall. These devices can cause serious injuries, or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall for its Cortrak*2 oral access device. 629 devices, distributed from 2016 - 2022, were recalled by the U.S. starting on March 21.
Cortrak*2 lets clinicians insert medical feeding tubes inside the small bowel or stomach of patients who require nutrition.
The recall was triggered by injury and death reports of patients suffering from nasocentric/nasogastric tube placement error. The device is used to assist in placing the tubes. An error in inserting a Nasogastric or Nasoenteric tube could result in severe injury or even death.
According to Avanos Safety communications the number of injuries was 60 and 23 fatalities related to this issue. The adverse events that were mentioned included respiratory failure, perforation and pneumonia, in addition to the development of pleural effusion.
Cortrak*2 has used this recall to improve its instructions for use and intended uses. https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical Avanos Medical Users will need to verify the location of tubes based on established protocols before they can deliver nutrition.
https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Clinicians were also advised to include the field correction notice about the issue to the operating guideline and return the acknowledgement form that was included with the notification to Avanos. The company plans to offer users the most current labeling, along with confirmation of the placement of the tube in accordance with the institutional guidelines.
Avanos Mediacal Cortrak 2
Website: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical
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