Recall Z-2176-2025 ยท FPA Set, Administration, Intravascular
B BRAUN MEDICAL INC
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
| Date | Aug 6, 2025 (initiated Jul 9, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | B. Braun Medical notified consignees of the recall on about 07/09/2025 via "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 07/02/2025. The letter described the product, problem and actions to be taken. Consignees were instructed to ensure all users within your organization as well as customers, if further distributed, are notified of the recall and provided the notification letter. Review inventory and determine if any affected units are on hand, cease use and quarantine product-Do not destroy any affected product. Complete and return the Urgent Medical Device Recall Acknowledgement F |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902409 | BECTON DICKINSON 360 INFUSER (TM) SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic, Jul 19, 1990 |