FDAClass IIJuly 17, 2024

Dianeal Low Calcium recall: Sterility Concern

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only…

Why was Dianeal Low Calcium recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 R24B25FA; Exp. 2/28/2026

Product
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only…
Recalling firm
Baxter Healthcare Corporation
Quantity
6,874 bags
Distribution
US Nationwide, Canada
Recall date
July 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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