DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.

Reason: Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.

Code information: Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019

Distribution pattern: Product was distributed throughout the United States to patients and clinics.