B BRAUN MEDICAL product recalled over sterility concerns
- Recall date
- August 4, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- B BRAUN MEDICAL INC recalls 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose contain…
- Recall number
- D-0586-2025
- FDA classification
- Class II
- Brand / firm
- B BRAUN MEDICAL INC
- Sold / distributed
- Nationwide in the US
Why it was recalled
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
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