STERILE WATER FOR INJECTION USP recalled over sterility concerns
- Recall date
- August 26, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- B BRAUN MEDICAL INC recalls STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
- Recall number
- D-0652-2025
- FDA classification
- Class II
- Brand / firm
- B BRAUN MEDICAL INC
- Sold / distributed
- U.S. Nationwide
Why it was recalled
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Get recall alerts
Free email alert whenever B BRAUN MEDICAL INC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: B BRAUN MEDICAL INC