FDAClass IIJuly 28, 2021

NaturaLyte Dry Bicarbonate Concentrate is composed of recall

NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a…

Why was NaturaLyte Dry Bicarbonate Concentrate is composed of recalled?

Exposed to freezing temperatures due to refrigerated truck malfunctions

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: 21ATBC004 UDI: (01)00840861101955

Product
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a…
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
120 Bags
Distribution
US Distribution to: TX only
Recall date
July 28, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls