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Drug FDA Class II Ongoing Contamination / non-sterility

0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.

B BRAUN MEDICAL INC Published Sep 24, 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

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Hazards

Lack of Sterility Assurance due to Port Misalignment · primary

Affected products (1)

0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.

SODIUM CHLORIDE FOR IRRIGATION · 16,228 3000 mL bags

NDC: 0264-7388, 0264-7388-50, 0264-7388-60
Code info: Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 26, 2025
  2. Published
    Sep 24, 2025
Recall number
D-0653-2025
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.