Drug 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.
D-0586-2025
Product summary
- Event
- Event 97368
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23,100 containers
- Official record key
drug-enforcement:D-0586-2025
Official wording
Reason: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Code information: Lot #: J5C919, Exp. 08/31/2027
Distribution pattern: Nationwide in the US
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility