Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.

Recall Number: D-1610-2014

Firm: Baxter Healthcare Corp.

Classification: Class I

Status: Terminated

Report Date: 20141008

Initiation Date: 20140807

Termination Date: 20170428

Reason for Recall

Presence of Particulate Matter: particulate matter was found during the manufacturing process.

Product Description

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.