Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11

Recall Number: D-1276-2014

Firm: Baxter Healthcare Corp.

Classification: Class I

Status: Terminated

Report Date: 20140507

Initiation Date: 20140211

Termination Date: 20150722

Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.

Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11