Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.

Recall Number: D-0543-2023

Firm: Baxter Healthcare Corporation

Classification: Class II

Status: Completed

Report Date: 20230503

Initiation Date: 20230315

Termination Date:

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.