D-1141-2023 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Drugs
Report Date
September 6, 2023
Initiation Date
August 11, 2023
Termination Date
July 16, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22,112 bags

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot Y406734, Exp 31-Oct-2024