Class IIReported 2025-04-16

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

Reason for Recall

Presence of Particulate Matter

Recall Number

D-0353-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-03-31

Reported

2025-04-16

Distribution

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

Code Info

Lot # J4K936, Exp 7/31/2027

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.