Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperiton...
FDA Recall #D-0587-2024 — Class II — June 17, 2024
Product Description
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly 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
6,874 bags
Distribution
US Nationwide, Canada
Code Information
Lot R24B25FA; Exp. 2/28/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated