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Recall Observatory FDA recall evidence

Drug product

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

D-0652-2025

August 26, 2025

Class II

Product summary

Firm
B BRAUN MEDICAL INC
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility