Class II Recall

B BRAUN MEDICAL INC

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
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Classification
Class II
Status
Ongoing
Lot
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.