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: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Code information: Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.

Distribution pattern: US Nationwide.