CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L recalled
Fresenius Medical Care Renal Therapies Group is recalling NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, distributed in California, Florida, Kansas, Louisiana, Texas. The recall was initiated on 29 Sep 2017 and the FDA has classified it as Class II.
Check your package
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-1010-2018
- FDA event ID
- 79236
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Sep 2017
- FDA classified
- 14 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 Sep 2017 | Recall initiated by company | |
| 14 Mar 2018 | Classified by FDA | +166 days |
| 21 Mar 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
Product as listed by the FDA
NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle 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.
Where it was distributed
US Distribution to states of: CA, FL, KS, LA, and TX.
Questions about this recall
Why was it recalled?
The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
Which lots are affected?
Lot # 17KTAC076; UDI-00840861101696
Where was it sold?
US Distribution to states of: CA, FL, KS, LA, and TX.
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
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CombiSet Hemodialysis Blood Tubing Set recalled | Fresenius Medical Care Renal Therapies Group | Other | Nationwide |
| Device | CLASS II | 5008X HD/HDF with CLiC Blood Tubing Set recalled | Fresenius Medical Care Renal Therapies Group | Packaging Defects | Nationwide |
| Device | CLASS II | 5008X HD/HDF Standard Blood Tubing Set recalled | Fresenius Medical Care Renal Therapies Group | Packaging Defects | Nationwide |
| Device | CLASS II | Citrasate, Liquid Acid Concentrate recalled | Fresenius Medical Care Renal Therapies Group | Other | Nationwide |
| Device | CLASS II | NaturaLyte, Liquid Acid Concentrate recalled | Fresenius Medical Care Renal Therapies Group | Other | Nationwide |
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