FDA-Device2025-08-13Class I

Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.

B BRAUN MEDICAL INC
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-2176-2025

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