Recall Z-0193-2027— B Braun Medical Inc

Name: FDA recall Z-0193-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-14

Class II · Ongoing

Class II FDA medical device recall by B Braun Medical Inc, initiated 2026-09-14. It names one FDA 510(k) clearance: K942988. Product: B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.. Reason: Potential for leakage and backflow at the Safsite valve..

Recalling firm: B Braun Medical Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-09-14
Firm location: Bethlehem, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K942988 — FILTERED EXTENSION SETSB. Braun of America, Inc.·cleared 1995-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.

Reason for recall

Potential for leakage and backflow at the Safsite valve.

Data sourced from openFDA. This site is unofficial and independent of the FDA.