Product: 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.
Reason for recall: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Recall initiated: 20230315
Status: Completed
Classification: Class II
Recall type: Voluntary: Firm initiated