PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: April 16, 2025 Initiated: March 31, 2025 #D-0353-2025

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

Details

Recalling Firm
B. Braun Medical Inc
Units Affected
32,256 Bottles
Distribution
Product was distributed to 12 distributors who may have further distributed the product nationwide.
Location
Irvine, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by B. Braun Medical Inc. Units affected: 32,256 Bottles.
Why was this product recalled?
Presence of Particulate Matter
Which agency issued this recall?
This recall was issued by the FDA Drug on April 16, 2025. Severity: Moderate. Recall number: D-0353-2025.