FDA Drugs recall ·
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION… recall
- Recall number
- D-0653-2025
- Date
- (initiated August 26, 2025)
- Company / brand
- B Braun Medical Inc
861 Marcon Blvd, Allentown, PA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 16,228 3000 mL bags
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
Distribution
U.S. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0653-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.