FDA-Device2026-10-16Class IIPROCESSING DEFECT
B. Braun SAFSITE Injection Site valve recalled for leakage and backflow risk
What this means
B. Braun Medical Inc is recalling certain SAFSITE Injection Site valves (model RV1000NC, catalog number 415068) because they may leak or allow blood to flow backward into the IV line. This could affect the safety of IV therapy. The recall affects specific lot numbers with expiration dates in September and October 2029.
- Check if your facility uses B. Braun SAFSITE valves with catalog number 415068 and the affected lot numbers (0061968348 or 0061966913).
- Stop using affected valves immediately and do not use them for patient care.
- Contact B. Braun Medical Inc or your supplier for instructions on replacement or return.
The agency's original wording
Hazard
Potential for leakage and backflow at the Safsite valve.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
461,300 units
Manufactured in
824 12th Ave, Bethlehem, Pennsylvania, United States
Products
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0193-2027More B. Braun recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.