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AVANOS MEDICAL RECALLS CORTRAK*2 ENTERAL ACCESS SYSTEM FOR RISK OF MISPLACED ENT

Expires in 12 hours

06 January 2023

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The FDA has identified this as a Class I recall, the most serious type of
recall. Use of these devices may cause serious injuries or death.



Recalled Product



Product Name: Avanos Medical Cortrak*2 Enteral Access System

Product Codes and Serial Numbers: See recall database entry

Distribution Dates: April 1, 2016 to January 1, 2022



Devices Recalled in the U.S.: 629

Date Initiated by Firm: March 21, 2022



Device Use



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.





Reason for Recall

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.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery





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).





Who May be Affected



Health care personnel who use the Avanos Medical Cortrak*2 Enteral Access System
to place feeding tubes in their patients.

People who have a feeding tube placed with assistance from the Avanos Medical
Cortrak*2 Enteral Access System. Avanos Medical feeding tube





What to Do

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.



Contact Information

Customers with questions or concerns about this recall should contact Avanos
Medical by phone at 470-448-5444 or by emailing gpms-ha-reporting@avanos.com.





Additional Resources



Medical Device Recall Database Entry



How do I report a problem? Avanos Medical feeding tube Cortrak 2 eternal access
system

Health care professionals and consumers may Avanos Medical feeding tube
action=reporting.home">report adverse reactions or quality problems they
experienced using these devices to MedWatch: The FDA Safety Information and
Adverse Event Reporting Program using an online form, regular mail, or FAX.



Source:



https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause

My Website:
https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/



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