STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC...
FDA Recall #D-0652-2025 — Class II — August 26, 2025
Product Description
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Reason for Recall
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Recalling Firm
B BRAUN MEDICAL INC — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
26,316 3000 mL bags
Distribution
U.S. Nationwide
Code Information
Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated