Drug recall D-1141-2023

Class II Terminated reported Sep 6, 2023

Product

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.

Lots and codes

Lot Y406734, Exp 31-Oct-2024

Recall details

Recalling firm
Baxter Healthcare Corporation, Deerfield, IL
Quantity
22,112 bags
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
August 11, 2023
Terminated
July 16, 2024

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