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.
Recall Number: D-0497-2026
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
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.