The Recall Desk
HighFDA (Devices)·Z-0817-2021·Announced 2021-01-20

Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used in hemodialysis with a defect in chemical composition (low sodium/calcium). Per the rubric, this is a risk-of-harm product where injury has not yet been reported, corresponding to a score of 3.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8. The recall involves 577 cases distributed nationwide in the United States. The affected lot numbers are 20LXAC097 and 20NXAC033.

The recall was initiated because the sodium and/or calcium levels in these concentrates were below the manufacturing specifications. These products are used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Patients and healthcare facilities using these specific lot numbers should stop using the product and contact their supplier or Fresenius Medical Care for further instructions.

The recalled product

Product
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Manufacturer
Fresenius Medical Care Holdings, Inc.
Category
Medical Device — Dialysis Supplies
Hazard
Affected units
577

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 20LXAC097 Additional affected lot as of 3/17/21: 20NXAC033

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

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