Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07

Recall Number: D-1141-2023

Firm: Baxter Healthcare Corporation

Classification: Class II

Status: Terminated

Report Date: 20230906

Initiation Date: 20230811

Termination Date: 20240716

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

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07