Class IIOngoing

0.9% Sodium chloride Irrigation USP recall

FDA recall D-0353-2025 · initiated Mar 31, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Presence of Particulate Matter

Details

Product: 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
Recalling company: B Braun Medical
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Product was distributed to 12 distributors who may have further distributed the product nationwide.
Initiated: Mar 31, 2025
FDA report date: Apr 16, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0353-2025 ↗

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