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Drug FDA Class II Ongoing Foreign material

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

B. Braun Medical Inc Published Apr 16, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact B. Braun Medical Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of Particulate Matter

Hazards

Particulate Matter · primary

Affected products (1)

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

SODIUM CHLORIDE · 32,256 Bottles

NDC: 0264-2201, 0264-2201-00, 0264-2201-10, 0264-2201-50, 0264-2201-70
Lot codes: J4K936
Code info: Lot # J4K936, Exp 7/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 31, 2025
  2. Published
    Apr 16, 2025
Recall number
D-0353-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.