Dialysis Solution Recalled for Potential Leaks

Baxter Healthcare Corporation is recalling 6 874 bags of Dianeal low calcium (2.5 mEq/L) peritoneal dialysis solution with 2.5% dextrose because of sterility concerns stemming from potentially leaky bags, according to the July 17, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects Dianeal low calcium (2.5 mEq/L) peritoneal dialysis solution with 2.5% dextrose, 6 000 mL per bag (NDC 0941-0457-01), from lot R24B25FA (Exp. 2/28/26). The bags were distributed throughout the United States and Canada.

Baxter Healthcare Corporation voluntarily initiated the recall on June 17, 2024. On July 6, 2024, the FDA designated the recall Class II. Per the classification, use of the drug could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Dianeal peritoneal dialysis solution is indicated for patients in acute or chronic renal failure.