Drug recall 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 0264-7388-60.
Reason for recall
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Lots and codes
Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
Recall details
- Recalling firm
- B BRAUN MEDICAL INC, Allentown, PA
- Quantity
- 16,228 3000 mL bags
- Distribution
- U.S. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 26, 2025
Related products
- Sodium Chloride for Irrigation – drug information
- NDC 0264-7388 Sodium Chloride for Irrigation · Sodium Chloride .9 g/100mL · B. Braun Medical Inc.