Recall Z-0193-2027 ยท FPA Set, Administration, Intravascular
B Braun Medical Inc
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
| Date | Oct 16, 2026 (initiated Sep 14, 2026) |
| Status | Open, Classified |
| Reason | Potential for leakage and backflow at the Safsite valve. |
| Root cause | Process control |
| Action | B. Braun notified consignees on about 09/14/2026 via mailed "URGENT MEDICAL DEVICE REMOVAL NOTIFICATION" letter. Consignees were instructed to ensure all users within the organization are aware of the recall, notify customers if affected units were furhter distributed, review current inventory and quarantine any units on hand, and complete and return the "Urgent Medical Device Recall Acknowledgement Form" with the total number of units on hand. B. Braun Customer Support will arrange the return of affected units. |
| Quantity | 461,300 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, MN, NJ, NY, OH, PA, TX, WA and the countries of Australia, Germany Malaysia, New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942988 | FILTERED EXTENSION SETS B. Braun of America, Inc., Jul 14, 1995 |