FDAClass IIApril 16, 2025

0.9% Sodium chloride Irrigation USP recall: Particulate Matter

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

Why was 0.9% Sodium chloride Irrigation USP recalled?

Presence of Particulate Matter

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # J4K936, Exp 7/31/2027

Product
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem…
Recalling firm
B. Braun Medical Inc
Quantity
32,256 Bottles
Distribution
Product was distributed to 12 distributors who may have further distributed the product nationwide.
Recall date
April 16, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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