Nxstage Medical Inc: Delflex Peritoneal Dialysis Solution With 4.25% Dextrose, Low Magnesium/ Low Calcium And Attached Stay Safe Exchange Set, 2

Recalling firm
NxStage Medical Inc
Product
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium/ Low Calcium and Attached stay safe Exchange Set, 2,500 mL Single dose bag, Sterile and Non-Pyrogenic, Rx only, CAT.NO. 054-25324. Fresenius Medical Care, Renal Therapies Group, LLC, Lawrence, MA 01843. NDC 46163-212-94
Reason
Lack of Assurance of Sterility
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-10-14
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide in the USA.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/5b39b4f5-78ab-4317-b597-b665cd5ad90c