US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 2, 2019 (8 years ago)

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
Baxter Healthcare Corporation
NDC code
0941-0424-52
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0351-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.