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.

Recall Number: D-0586-2025

Firm: B BRAUN MEDICAL INC

Classification: Class II

Status: Ongoing

Report Date: 20250820

Initiation Date: 20250804

Termination Date:

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

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.