Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.

Recall Number: D-0351-2019

Firm: Baxter Healthcare Corporation

Classification: Class II

Status: Terminated

Report Date: 20190116

Initiation Date: 20190102

Termination Date: 20200429

Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.