0.9% Sodium Chloride Irrigation Usp. Isotonic Solution 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…
Why was 0.9% Sodium Chloride Irrigation Usp. Isotonic Solution 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?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
- 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 date
- September 24, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)