FDAFDA · Food and drugs·Recall number D-0586-2025
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.
Published August 20, 2025 · Recall initiated: August 4, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SODIUM CHLORIDE
- Manufacturer
- B BRAUN MEDICAL INC
- Distributor
- Nationwide in the US
- Lot
- Lot #: J5C919, Exp. 08/31/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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