Class I — B BRAUN MEDICAL INC
| Recalling firm | B. BRAUN MEDICAL INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| Product | Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing. |
| Quantity | 34,825 units US |
| 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. |
| Initiated | 2025-07-09 |
| Classified | 2025-08-06 |
| Recall number | Z-2176-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — B BRAUN MEDICAL INC (Z-2176-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97167/
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