Sterility Concerns Prompt Dialysis Solution Recall

Fresenius Medical Care Holdings Inc. is recalling 69,590 bags of Delflex peritoneal dialysis solution because of sterility concerns, according to the January 10, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Delflex peritoneal dialysis solution, 1.5% dextrose, packaged in 6000-mL Biofine bags (NDC 49230-206-62), from lot 23JK02010 (Exp. 1/31/25). The product was distributed throughout the United States.

Fresenius Medical Care Holdings voluntarily initiated the recall December 28, 2023. On January 4, 2024, the FDA designated the recall Class II. Per the classification, use of the affected solution may cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Delflex is a sterile formulation of dextrose and electrolytes in water. It is used in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.