Home / Recalls / Baxter Healthcare Corporation / D-1140-2023

D-1140-2023 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
a) 44,520; b) 60,762; c) 483,912

Product Description

DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

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

a) Lots Y403948, Exp 30-Sep-2024; Lot Y406277, Exp 31-Oct-2024. b) Lot 408790, Exp 30-Nov-2024 and c) Lots Y403740, Y403740A, Exp 30-Sep-2024; Lots Y405638, Y405805, Y407304, Y407304A Exp 31-Oct-2024; Lots Y407717, Y407717A, Y408554, Exp 30-Nov-2024; Lot Y420075, Exp 30-Apr-2025

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