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.
Recall Number: D-0495-2026
Firm: B BRAUN MEDICAL INC
Classification: Class II
Status: Ongoing
Report Date: 20260429
Initiation Date: 20260402
Termination Date:
Reason 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.