Product: 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
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