CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis recalled

Fresenius Medical Care Renal Therapies Group is recalling NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, distributed nationwide in the US. The recall was initiated on 2 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: 18CXAC095

Quantity recalled1060 cases (4240 bottles)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2110-2018
FDA event ID: 80101
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 2 May 2018
FDA classified: 7 Jun 2018
Reported: 13 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

2 May 2018	Recall initiated by company
7 Jun 2018	Classified by FDA	+36 days
13 Jun 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The bottles are mislabeled with an incorrect part number.

Product as listed by the FDA

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.

Where it was distributed

Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.

Nationwide California Iowa Illinois Indiana Kansas Maryland Michigan Minnesota Mississippi Nebraska New Jersey Nevada Oklahoma Pennsylvania South Dakota Texas Wisconsin

Questions about this recall

Why was it recalled?

The bottles are mislabeled with an incorrect part number.

Which lots are affected?

Lot Code: 18CXAC095

Where was it sold?

Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Fresenius Medical Care Renal Therapies Group

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30 Sep 2026Device	CLASS II	CombiSet Hemodialysis Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	5008X HD/HDF with CLiC Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	5008X HD/HDF Standard Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Citrasate, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	NaturaLyte, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide

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