CLASS II ONGOING Device recall · Reported 20 Jan 2021 · FDA Enforcement Report
NaturaLyte Liquid Acid concentrate recalled by Fresenius Medical Care
Fresenius Medical Care Holdings is recalling NaturaLyte Liquid Acid concentrate, distributed nationwide in the US. The recall was initiated on 7 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-0818-2021
- FDA event ID
- 86855
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Nov 2020
- FDA classified
- 11 Jan 2021
- Reported
- 20 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Nov 2020 | Recall initiated by company | |
| 11 Jan 2021 | Classified by FDA | +65 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 sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Product as listed by the FDA
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - 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
Is NaturaLyte Liquid Acid concentrate recalled?
Yes. Fresenius Medical Care Holdings recalled NaturaLyte Liquid Acid concentrate on 7 Nov 2020. The recall is Class II and its status is Ongoing. Recall number Z-0818-2021.
Why was it recalled?
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
Which lots are affected?
Lot Numbers: 20LXAC038 20NXAC032
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 21 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 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 |