FDA MedWatch - Cortrak*2 Enteral Access System by Avanos Medical: Class I Recall

Risk of Misplaced Enteral Tubes Could Cause Patient Harm

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Cortrak*2 Enteral Access System by Avanos Medical: Class I Recall - Risk of Misplaced Enteral Tubes Could Cause Patient Harm AUDIENCE: Health Professional, Patient, Risk Manager, Gastroenterology, Pulmonology    ISSUE: Avanos Medical is recalling the Cortrak*2 Enteral Access System because there have been reports of injuries and patient deaths after nasoenteric or nasogastric tubes have been misplaced when this device is used to help with their placement. This recall is being used to make updates to the device's labeling, including the instructions for use and intended uses. The updates instruct users to confirm tube placement based on their institution's protocols before using the tube to deliver nutrition. If a nasogastric or nasoenteric tube is inserted incorrectly, patients could experience damage to the vocal cords, lungs, or trachea, all of which can lead to serious injury or death. According to Avanos Medical's recall communication, there have been 60 injuries and 23 patient deaths related to misplacement of nasogastric feeding tubes while using the CORTRAK* 2 Enteral Access System, since 2015. Adverse events reported included respiratory failure, pneumothorax (collapsed lung), perforation (a hole in the wall of the lung, esophagus, or bowel), pneumonia (a lung infection), and pleural effusion (excess fluid in the space between the lungs and the chest cavity). For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Avanos Medical CORTRAK* 2 Enteral Access System is designed to help trained health care personnel place medical feeding tubes into the stomach or small bowel of patients who need to receive nutrition through the tube. RECOMMENDATIONS: On March 21, 2022, Avanos Medical issued a field correction notice to its customers who used these devices between January 2021 and January 2022. The notice included the following instructions: Confirm placement of nasogastric and nasoenteric tubes according to institutional policies. Attach the field correction notice about the issue to the operator's manual. Return the acknowledgement form included with the emailed notice to Avanos Medical. In the near future, Avanos Medical intends to provide users with updated labeling, including the step for users to confirm placement of nasogastric and nasoenteric tubes according to institutional policies before use. Customers will need to return another acknowledgement form after they received the updated information. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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