Extension Set recallZ-2176-2025 · B Braun Medical Inc · initiated Jul 9, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B Braun Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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: [email protected] 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.
Recall details
- Recall number
- Z-2176-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 9, 2025
- Posted by the FDA
- Aug 6, 2025
- Recalling firm
- B Braun Medical Inc
- Quantity
- 34,825 units US
- Product code
- FPA
- FDA submissions
- K902409
- Distribution
- US distribution to AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WY. International distribution to Canada.
Product description
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Code information (models, lots, serial numbers)
Catalog Number: V6215. Primary UDI-DI 04046964189173, Unit of Use UDI-DI: 04046964189166. Lot Number (Expiration Date): 0061742452 (30JUN2025), 0061747379 (31AUG2025 0, 0061767411 (31JAN2026), 0061780914 (30APR2026), 0061803499 (30SEP2026), 0061806173 (30NOV2026), 0061822333 (30APR2027), 0061836578 (30APR2027), 0061849109 (31JUL2027), 0061850836 (31AUG2027), 0061899902 (30SEP2028), 0061936368 (31MAR2029), 0061936119 (31MAR2029), 0061936369 (31MAR2029), 0061940584 (30APR2029).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Extension Set V6215B. Braun Medical Inc. · Set, administration, intravascular1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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