Microbore Extension Set (B.Braun) – Labeling Inaccuracy (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.

Recommended Action

Per FDA guidance

B. Braun Medical notified consignees of the recall on about 07/09/2025 via "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 07/02/2025. The letter described the product, problem and actions to be taken. Consignees were instructed to ensure all users within your organization as well as customers, if further distributed, are notified of the recall and provided the notification letter. Review inventory and determine if any affected units are on hand, cease use and quarantine product-Do not destroy any affected product. Complete and return the Urgent Medical Device Recall Acknowledgement Form via fax to (610) 849-1197 or email to: recalls@bbraunusa.com and arrange for the return of affected units. Once the firm receives the Acknowledgement form a customer support representative will contact you with instructions on how to return the product. For questions about this recall, please contact our BBMI's Recalls Department at 844-903-6417.

Distribution

As reported by FDA

AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, ME, MD, MA, MI, MN, MS, MO, NV, NJ, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WY