US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 11, 2023 (3 years ago)

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll…

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, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07

Recalling firm
Baxter Healthcare Corporation
NDC code
0941-0411-07
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1141-2023

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.