B BRAUN MEDICAL INC recalls 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524,
Recalled April 29, 2026 · FDA recall D-0497-2026 · B BRAUN MEDICAL
Hazard
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. · FDA Class II
Units
124,244 bags
Sold at
US Nationwide.
Description
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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.
Manufacturer(s)
B BRAUN MEDICAL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →