Recalling firm
B BRAUN MEDICAL INC
Product type
Drug
Status
Ongoing
Report date
2025-09-24
Distribution
U.S. Nationwide
Firm state
PA
Product quantity
16,228 3000 mL bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Product description
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.
Code / lot info
Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
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.