FDAHealthAugust 4, 2025
B BRAUN MEDICAL INC — 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 0264-78
⚠️ Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 4, 2025
Nationwide in the US
What's affected?
- Product
- 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.
- Brand
- SODIUM CHLORIDE
- Lot code
- J5C919
Additional details
Lot #: J5C919, Exp. 08/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 23,100 containers.
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