B Braun Medical Inc medical device recall: Microbore Extension Set with 0.2 Micron Filter. Catalog Number:…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97167
- Recall initiated
- Jul 9, 2025
- Classified by FDA
- Aug 6, 2025
- Posted in Enforcement Report
- Aug 13, 2025
- Recalling firm
- B BRAUN MEDICAL INC
- Firm location
- Allentown, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jul 9, 2025. FDA classified it 28 days later, on Aug 6, 2025. Distribution reported by FDA: 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. B BRAUN MEDICAL INC has 91 recalls in our records.
Recalled products (1)
Z-2176-2025 Class I Ongoing
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Codes / lots: 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).
Quantity: 34,825 units US
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97167
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.