0.9% Sodium Chloride Irrigation USP Recall: Sterility Concern
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was 0.9% Sodium Chloride Irrigation USP recalled?
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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.
Which lot codes, UPCs or models are affected?
Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
- Agency record number
- D-0653-2025
- Product
- 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC…
- Recalling firm
- B BRAUN MEDICAL INC
- Quantity
- 16,228 3000 mL bags
- Distribution
- U.S. Nationwide
- Recall started
- August 26, 2025
- Report date
- September 24, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)