FDAClass IIJanuary 20, 2021

NaturaLyte Liquid Acid concentrate drums recall

NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium…

Why was NaturaLyte Liquid Acid concentrate drums recalled?

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

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?

Lot Numbers: 20LXAC030 20LXAC084 20NXAC002 20LXAC014 20NXAC018

Product
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium…
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
27 drums
Distribution
US Nationwide distribution.
Recall date
January 20, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls