FDAClass IIAugust 19, 2015

Naturalyte Liquid Bicarbonate Concentrate 6.4 liter recall: Contamination

Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB

Why was Naturalyte Liquid Bicarbonate Concentrate 6.4 liter recalled?

Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.

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?

Lots begin with: 15AMLB, 15BMLB, 15CMLB.

Product
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
2,264,028
Distribution
Nationwide Distribution
Recall date
August 19, 2015
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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