US Drug Recall Register
Class II · Moderate risk Completed Initiated Mar 15, 2023 (3 years ago)

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II…

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

Why it was recalled

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

What was recalled

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.

Recalling firm
Baxter Healthcare Corporation
NDC code
0941-0411-04
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0543-2023

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.