FDA recall Z-2176-2025

B BRAUN MEDICAL INC · Class I · device

Product

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

Reason for recall

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-07-09
Report date
2025-08-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2176-2025