Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1739-2022 — 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: AC

U.S. FDA — Device Enforcement · United States · 2022-07-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1739-2022
Date of alert: 2022-07-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Isopure Corp
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00852456007092

Reported risk: Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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