B BRAUN MEDICAL product 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 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehe…
- Recall number
- D-0653-2025
- 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
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
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