FDA-Device2025-08-13Class I
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Hazard
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.
Sold states
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.
Affected count
34,825 units US
Manufactured in
861 Marcon Blvd, N/A, Allentown, PA, United States
Products
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2176-2025More B BRAUN MEDICAL INC recalls
- FDA-Device2026-04-22B. Braun StreamLine Bloodline hemodialysis tubing recalled for air bubble accumulation risk
- FDA-Device2026-04-22B. Braun STREAMLINE BLOODLINE SET recalled for air bubble risk in hemodialysis
- FDA-Device2026-04-22B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- FDA-Device2026-04-22B Braun hemodialysis bloodlines recalled for potential air bubble accumulation in arterial line
- FDA-Device2026-04-22B. Braun hemodialysis bloodlines recalled for potential air bubble accumulation
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