Device recall
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
- Recall number
- Z-0193-2027
- Event id
- 99879
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- B Braun Medical Inc
- Report date
- Oct 28, 2026
- Posted
- Oct 16, 2026
- Initiated
- Sep 14, 2026
- Center classification date
- Oct 16, 2026
- Product code
- FPA
- Device type
- Set, Administration, Intravascular
- Reason
- Potential for leakage and backflow at the Safsite valve.
- Root cause
- Process control
- Quantity
- 461,300 units
- Code info
- Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K942988
- Location
- Bethlehem, PA, United States