Class IIReported 2025-08-20

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 Number

D-0586-2025

Classification

Class II

Status

Ongoing