0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation ...

FDA Recall #D-0353-2025 — Class II — March 31, 2025

Recall #D-0353-2025 Date: March 31, 2025 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

Presence of Particulate Matter

Recalling Firm

B. Braun Medical Inc — Irvine, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

32,256 Bottles

Distribution

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

Code Information

Lot # J4K936, Exp 7/31/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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