FDA-Drug2025-09-24Class II
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
B BRAUN MEDICAL INC
Hazard
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Sold states
U.S. Nationwide
Affected count
26,316 3000 mL bags
Manufactured in
861 Marcon Blvd, N/A, Allentown, PA, United States
Products
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2025Don't want to check this manually?
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