FDA-Drug2025-04-16Class II

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

Hazard

Presence of Particulate Matter

Sold states
Product was distributed to 12 distributors who may have further distributed the product nationwide.
Affected count
32,256 Bottles
Manufactured in
2525 Mcgaw Ave, N/A, Irvine, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0353-2025

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