B BRAUN MEDICAL INC recalls 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem
Recalled September 24, 2025 · FDA recall D-0653-2025 · B BRAUN MEDICAL
Hazard
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. · FDA Class II
Units
16,228 3000 mL bags
Sold at
U.S. Nationwide
Description
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
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.
Manufacturer(s)
B BRAUN MEDICAL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →