FDAHealthAugust 26, 2025
B BRAUN MEDICAL INC — 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.
⚠️ Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 26, 2025
U.S. Nationwide
What's affected?
- Product
- 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.
- Lot code
- :
Additional details
Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 16,228 3000 mL bags.
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