Product: 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 for recall: Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Recall initiated: 20171220
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated