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.

Recall Number: D-0604-2018

Firm: Fresenius Medical Care Renal Therapies Group, LLC

Classification: Class II

Status: Terminated

Report Date: 20180328

Initiation Date: 20171220

Termination Date: 20190214

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

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.