Recalling firm
B BRAUN MEDICAL INC
Product type
Drug
Status
Ongoing
Report date
2026-04-29
Distribution
US Nationwide.
Firm state
PA
Product quantity
24,928 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Product description
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
Code / lot info
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
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.