Recall archive / FDA device enforcement
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing. — FDA record Z-2176-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 9, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- B BRAUN MEDICAL INC
- Quantity
- 34,825 units US
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2176-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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). |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 13, 2025
- Recall initiation date
- Jul 9, 2025
- Center classification date
- Aug 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.