0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogeni...
FDA Recall #D-0586-2025 — Class II — August 4, 2025
Product Description
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.
Recalling Firm
B BRAUN MEDICAL INC — Allentown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
23,100 containers
Distribution
Nationwide in the US
Code Information
Lot #: J5C919, Exp. 08/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated