B BRAUN MEDICAL INC recalls 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx onl
Recalled July 2, 2025 · FDA recall D-0491-2025 · B BRAUN MEDICAL
Hazard
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks. · FDA Class II
Units
187,656 containers
Sold at
USA Nationwide
Description
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Product
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Manufacturer(s)
B BRAUN MEDICAL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →