Acidified Concentrate Distribution and Storage-The Isopure ACDS — Class II medical device recall Z-1739-2022
Terminated recall by Isopure Corp, reported 2022-09-21, distributed nationwide. Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arc
| Recall number | Z-1739-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Isopure Corp, Louisville, KY, United States |
| Recall initiated | 2022-07-26 |
| Classified | 2022-09-14 |
| Reported by FDA | 2022-09-21 |
| Terminated | 2024-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 595 units |
| UPC / GTIN / UDI-DI | 00852456007092 |
| Serial numbers | 117546, 848370, 850159, AC--852733, AC-02041204, AC-113027, AC-113451, AC-113494, AC-113554, AC-114586, AC-114598, AC-114609, AC-114772, AC-115347, AC-115358, AC-115726, AC-115737, AC-115794, AC-115839, AC-115850, AC-116271, AC-116282, AC-116342, AC-116353, AC-116404 and 475 more |
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
Reason for recall
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1739-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.