Fresenius Medical Care Renal Therapies Group, LLC recalls DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2
Recalled March 28, 2018 · FDA recall D-0604-2018 · Fresenius Medical Care Renal Therapies Group
Hazard
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. · FDA Class II
Units
3,734 cases
Sold at
Product was distributed throughout the United States to patients and clinics.
Description
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
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.
Manufacturer(s)
Fresenius Medical Care Renal Therapies Group, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →