B. Braun Medical Inc recalls 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Br…

Recall date

March 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0353-2025

FDA classification

Class II

Brand / firm

B. Braun Medical Inc

Sold / distributed

Product was distributed to 12 distributors who may have further distributed the product nationwide.

Why it was recalled

Presence of Particulate Matter

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10