FDAClass IISeptember 6, 2023

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% recall: Sterility Concern

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare…

Why was Dianeal PD-2 Peritonial Dialysis Solution with 1.5% recalled?

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Y406734, Exp 31-Oct-2024

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…
Recalling firm
Baxter Healthcare Corporation
Quantity
22,112 bags
Distribution
Nationwide in the USA
Recall date
September 6, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls