Dialysis Solutions Recalled

Sterility concerns from potential leaks have prompted Baxter Healthcare Corporation to recall nearly 280,000 bags of Dianeal peritoneal dialysis solution, according to the May 3, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following Dianeal peritoneal dialysis products, which were distributed throughout the United States: 

• Dianeal low calcium (2.5 mEq/L) peritoneal dialysis solution with 1.5% dextrose, in 5000-mL Ambu-Flex II container bags (NDC 0941-0409-07), from lot Y406130 (Exp 10/31/24);
• Dianeal low calcium (2.5 mEq/L) peritoneal dialysis solution with 1.5% dextrose, in 6000-mL per Ambu-Flex II container bags (NDC 0941-0409-01), from lots Y406314, Y406314A, Y406963, and Y407199 (Exp 10/31/24); and
• Dianeal PD-2 peritoneal dialysis solution with 1.5% dextrose, 3000-mL Ambu-Flex II container bags (NDC 0941-0411-04), from lot Y405201 (Exp 10/31/24).

Baxter Healthcare Corporation voluntarily initiated the recall March 15, 2023. On April 24, 2023, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Dianeal peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.