B BRAUN MEDICAL product recalled over sterility concerns

Recall date

June 16, 2025

Source

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

Official notice title

B BRAUN MEDICAL INC recalls 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx on…

Recall number

D-0491-2025

FDA classification

Class II

Brand / firm

B BRAUN MEDICAL INC

Sold / distributed

USA Nationwide

Why it was recalled

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

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 Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.