Class II Recall

B BRAUN MEDICAL INC

Product
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
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 # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
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.
B BRAUN MEDICAL INC — Class II Recall | MedicineWatch US