Product: 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.
Reason for recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recall initiated: 20260402
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated