FDA Drug · D-0652-2025

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

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027

Recalling firm: B BRAUN MEDICAL INC, Allentown, PA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 26,316 3000 mL bags
Distribution: U.S. Nationwide
Recall initiated: August 26, 2025
Classified: September 16, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0652-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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