B BRAUN MEDICAL INC recalls STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Recalled September 24, 2025 · FDA recall D-0652-2025 · B BRAUN MEDICAL
Hazard
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. · FDA Class II
Units
26,316 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
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Manufacturer(s)
B BRAUN MEDICAL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →