D-0587-2024 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Drugs
Report Date
July 17, 2024
Initiation Date
June 17, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,874 bags

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.

Distribution Pattern

US Nationwide, Canada

Code Information

Lot R24B25FA; Exp. 2/28/2026