FDAClass IIAugust 8, 2012

Extraneal and/or DIANEAL LOW CALCIUM Peritoneal recall

Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis…

Why was Extraneal and/or DIANEAL LOW CALCIUM Peritoneal recalled?

Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette.

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?

all lots and serial numbers

Product
Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis…
Recalling firm
Baxter Healthcare Renal Div
Quantity
N/A
Distribution
Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia.
Recall date
August 8, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls