Dialysis Solution Recalled

Baxter Healthcare Corporation is recalling more than 500,000 bottles of Dianeal Low Calcium peritoneal dialysis solution because of a lack of assurance of sterility. According to the September 6, 2023, US Food and Drug Administration (FDA) Enforcement Report, the bags may contain leaks.

The recall affects Dianeal Low Calcium (2.5 mEq/L) peritoneal dialysis solution with 1.5% dextrose, packaged in:

• 2000-mL Ambu-Flex II container bags (product code L5B4825, NDC 0941-0409-06), from lots Y403948 (Exp 9/30/24) and Y406277 (Exp 10/31/24); 
• 5000-mL Ambu-Flex II container bags (product code L5B4826, NDC 0941-0409-07), from lot 408790 (Exp 11/30/24); and 
• 6000-mL Ambu-Flex II container bags (product code L5B9770, NDC 0941-0409-01), from lots Y403740 and Y403740A (Exp 9/30/24); Y405638, Y405805, Y407304, and Y407304A (Exp 10/31/24); Y407717, Y407717A, and Y408554 (Exp 11/30/24); and Y420075 (Exp 4/30/25).

The affected product was distributed throughout the United States.

Baxter Healthcare Corporation voluntarily initiated the recall August 11, 2023. On August 29, 2023, the FDA designated the recall Class II, communicating that 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 the management of acute or chronic renal failure.