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

FDA recall notice · announced April 16, 2025 · B. Braun Medical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Presence of Particulate Matter

Notes

Distribution: Product was distributed to 12 distributors who may have further distributed the product nationwide.
Lot/code information: Lot # J4K936, Exp 7/31/2027
Quantity: 32,256 Bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0353-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.