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

Recall Z-1026-2017 — Fresenius 2008T Series Hemodialysis System

U.S. FDA — Device Enforcement · United States · 2016-12-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1026-2017
Date of alert: 2016-12-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Fresenius Medical Care Renal Therapies Group, LLC
Product category: device
Product type: Devices

Reported risk: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

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.