Product: 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Reason for recall: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Recall initiated: 20250804
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated