NaturaLyte 13-2201-5Recalls & reported problems
Fresenius Medical Care Renal Therapies Group, LLC · NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Drum · Class 2
All models of NaturaLyte (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Jul 14, 2026Open, Classified
Complaints of blue-green discoloration in product
Z-3092-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Other DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) devices
- NaturaLyte 08-3251-9Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls78 reports
- NaturaLyte 08-2251-0Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)3 recalls1 death20 reports
- NaturaLyte 08-2301-3Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls35 reports
- Dry Acid Dissolution Unit 160147Fresenius Usa, Inc. · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)129 reports
- GranuFlo 0FD2251-3BFresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls1 death20 reports
- GranuFlo 0FD3251-3BFresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls1 death1 report
- Acidified Concentrate Distribution and Storage (ACDS) System MD704262Isopure, Corp. · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)2 recalls0 reports
- Bicarby RFP-400-GFresenius Medical Care Renal Therapies Group, LLC · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page