FDAHealthAugust 26, 2025
B BRAUN MEDICAL INC — STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
⚠️ 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
- STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
- Brand
- STERILE WATER
- Lot code
- J3L519
Additional details
Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 26,316 3000 mL bags.
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