FDA Drug Class II — Moderate

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

Hazard

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

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Products

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Brand
B BRAUN MEDICAL INC
UPC
Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027

Units Affected

26,316 3000 mL bags

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