CLASS II ONGOING Device recall · Reported 20 Jan 2021 · FDA Enforcement Report
Naturalyte Liquid Acid concentrate drums, Product recalled
Fresenius Medical Care Holdings is recalling Naturalyte Liquid Acid concentrate drums, distributed nationwide in the US. The recall was initiated on 23 Nov 2020 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-0840-2021
- FDA event ID
- 86939
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Nov 2020
- FDA classified
- 11 Jan 2021
- Reported
- 20 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Other Medical Devices
Timeline
| 23 Nov 2020 | Recall initiated by company | |
| 11 Jan 2021 | Classified by FDA | +49 days |
| 20 Jan 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: 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 Nationwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot Numbers: 20LXAC066 20LXAC089 Additional Affected lots as of 3/17/21: 20LXAC066 20LXAC073 20LXAC074 20LXAC024 20LXAC023 20LXAC072 20LXAC085 20LXAC089
Where was it sold?
US Nationwide distribution.
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.
Other products in this recall event
10 other products · FDA event 86939This product is part of a recall event; the main page for the event is Naturalyte Liquid Acid concentrate, Product recalled.
More recalls from Fresenius Medical Care Holdings
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 5008X Blood Tubing Set recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | Nationwide |
| Device | CLASS II | Bicarby" Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Packaging Defects | Nationwide |
| Device | CLASS II | Bicarby Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | TX |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |