D-0652-2025 Class II Ongoing

Recalled by B BRAUN MEDICAL INC — Allentown, PA

Recall Details

Product Type
Drugs
Report Date
September 24, 2025
Initiation Date
August 26, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26,316 3000 mL bags

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.

Distribution Pattern

U.S. Nationwide

Code Information

Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027