Class II

Drug Recall: 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.

B BRAUN MEDICAL INC · August 26, 2025

Reason for Recall

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

Distribution

U.S. Nationwide

States Affected

NATIONWIDE

Quantity Affected

16,228 3000 mL bags

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0653-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.