FDA-Drug2018-03-28Class II
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.
Fresenius Medical Care Renal Therapies Group, LLC
Hazard
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Sold states
Product was distributed throughout the United States to patients and clinics.
Affected count
3,734 cases
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0604-2018Don't want to check this manually?
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