NaturaLyte recallZ-0181-2023 · Fresenius Medical Care Holdings, Inc. · initiated Oct 4, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
FDA root cause category: Error in labeling
What the company is doing
On October 4, 2022, the firm notified affected customers via Important Medical Device Information letters. Customers were reassured that the product was manufactured according to specification and remains potassium-free. Customers may continue to use the product. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have further questions.
Recall details
- Recall number
- Z-0181-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 4, 2022
- Posted by the FDA
- Nov 4, 2022
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 17700
- Product code
- KPO
- FDA submissions
- K070177
- Distribution
- Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution.
Product description
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Code information (models, lots, serial numbers)
UDI-DI: 00840861101610 Lots: 20LTAC076 20PTAC094 21ATAC046 21BTAC082 21CTAC029 21KTAC072 21PTAC023 21STAC094 22DTAC036
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NaturaLyte 08-0231-4Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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