FDAClass IIJanuary 20, 2021

Naturalyte Liquid Acid concentrate bottles recall

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium…

Why was Naturalyte Liquid Acid concentrate bottles recalled?

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

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: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010 Additional Affected lots as of 3/17/21: 20LXAC053 20LXAC047 20LXAC054 20LXAC049 20NXAC016 20LXAC094 20NXAC024 20NXAC025 20LXAC091 20LXAC101 20LXAC077 20LXAC048 20NXAC010 20LXAC076

Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium…
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
3083 cases
Distribution
US Nationwide distribution.
Recall date
January 20, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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