D-0353-2025 Class II Ongoing

Recalled by B. Braun Medical Inc — Irvine, CA

Recall Details

Product Type
Drugs
Report Date
April 16, 2025
Initiation Date
March 31, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32,256 Bottles

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

Distribution Pattern

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

Code Information

Lot # J4K936, Exp 7/31/2027