Recall
FDAHealthMarch 31, 2025

B. Braun Medical Inc — 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-

⚠️ Presence of Particulate Matter

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 31, 2025

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

What's affected?

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
Lot code
J4K936

Additional details

Lot # J4K936, Exp 7/31/2027

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 32,256 Bottles.

View original FDA notice →

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