Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with...
FDA Recall #D-1141-2023 — Class II — August 11, 2023
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
22,112 bags
Distribution
Nationwide in the USA
Code Information
Lot Y406734, Exp 31-Oct-2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated