FDA issues Class I recall on B. Braun microbore extensions due to risk of death
The U.S. Food and Drug Administration said it’s aware that B. Braun has issued a recall on a line of its Microbore Extension Sets due to a labeling issue. The devices are single-use medical accessories that connect to IV lines to safely deliver or withdraw fluids, medications or blood products to patients.
In this case, the products were released with labels showing they have an air-eliminating filter, used to push air out of IV lines, ensuring it does not enter a patient’s bloodstream. However, the microbore extensions do not contain any such vent, despite them being commonly part of IV extensions.
For safety, they will need to be removed from where used or sold, until the packaging can be properly labeled to show the air vent is missing.
While B. Braun has reported no injuries associated with the issue, the high risk of a possibly fatal air embolism is enough to earn this recall the FDA’s Class I designation, the most serious type.
What's being recalled?
The mislabeled microbore extensions all share a single model number, though numerous lots are mislabeled. All the defective devices will need to be identified immediately, using the below chart as a guide.
Next Steps
Once identified, all of the products impacted by this recall must be quarantined immediately. They cannot be deployed in a patient care setting and will need to be returned to B. Braun for proper labeling. Do not destroy the microbores.
The company sent all known customers a letter with further instructions. Using the Urgent Medical Device Recall Acknowledgement Form, B. Braun asked that clinical settings and supply houses record their remaining inventory. The notice can then be sent to company, who will reach out to initiate a return.
Until such time as a return can be completed, alternative microbore extensions will need to be obtained.
Both the FDA and B. Braun asked that the recall notice be shared to aid in removing all mislabeled devices from the market. It can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.