Acidified Concentrate Distribution and Storage (ACDS) System MD704262Recalls & reported problems
Isopure, Corp. · Acidified Concentrate Distribution and Storage System (ACDS System) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier.
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 18, 2026.
Recalls naming this device
- Jul 26, 2022Class IITerminated
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
Z-1739-2022 · Root cause: Device Design · Recall details · FDA record ↗
- Apr 19, 2019Class IITerminated
There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron.
Z-0821-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
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- 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
- Bicarby RFP-400-GFresenius Medical Care Renal Therapies Group, LLC · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)2 recalls0 reports
- MedicaLyte BC+201Nipro Renal Solutions USA Corporation · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)1 recall1 death41 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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