Recalling firm
B BRAUN MEDICAL INC
Product type
Drug
Status
Ongoing
Report date
2025-08-20
Distribution
Nationwide in the US
Firm state
PA
Product quantity
23,100 containers
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Product description
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Code / lot info
Lot #: J5C919, Exp. 08/31/2027
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.