Recall D-0495-2026
Recalling firm
B BRAUN MEDICAL INC, PA
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.