FDAFDA · Food and drugs·Recall number D-0653-2025
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.
Published September 24, 2025 · Recall initiated: August 26, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SODIUM CHLORIDE FOR IRRIGATION
- Manufacturer
- B BRAUN MEDICAL INC
- Distributor
- U.S. Nationwide
- Lot
- Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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