FDAClass IMay 7, 2014

Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% recall: Particulate Matter

Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL…

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

Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.

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 number: C903799, Exp 05/15

Product
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL…
Recalling firm
Baxter Healthcare Corp.
Quantity
27,169 containers
Distribution
Nationwide.
Recall date
May 7, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls