FDAClass IIIJune 18, 2014

NaturaLyte¿ Liquid Bicarbonate Concentrate recall: Foreign Material

NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is…

Why was NaturaLyte¿ Liquid Bicarbonate Concentrate recalled?

Container cap may contain foreign material- 0.60% - 0.80% Manganese

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: 14CMLB006

Product
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is…
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
12 bottles
Distribution
Distributed in the state of MO.
Recall date
June 18, 2014
Classification
Class III
Status
Terminated
Agency
FDA (device)
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