Class II — Isopure Corp
| Recalling firm | ISOPURE CORP. |
|---|---|
| Registered facility | ISOPURE, CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching |
| Product | Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262 |
| Quantity | 595 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2022-07-26 |
| Classified | 2022-09-14 |
| Terminated | 2024-05-31 |
| Recall number | Z-1739-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Isopure Corp (Z-1739-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90739/
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