Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container ...
FDA Recall #D-0543-2023 — Class II — March 15, 2023
Product Description
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.
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
9,788 bags
Distribution
Nationwide in the USA
Code Information
Lot Y405201, Exp 31-Oct-2024
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated