B BRAUN MEDICAL INC recalls Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV…

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2176-2025
• FDA 510(k) clearance · K902409The device's official FDA premarket clearance record
• FDA device classification · FPAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find B BRAUN MEDICAL INCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.