Drug product
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
D-0652-2025
Product summary
- Event
- Event 97477
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26,316 3000 mL bags
- Official record key
drug-enforcement:D-0652-2025
Official wording
Reason: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Code information: Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility