FDA Drug · D-0653-2025

0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.

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#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.

Recalling firm: B BRAUN MEDICAL INC, Allentown, PA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 16,228 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-0653-2025%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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