Recall D-0586-2025

US Class II Ongoing · initiated 2025-08-04

Recalling firm

B BRAUN MEDICAL INC, PA

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.

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