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

Recall Z-1550-2015 — 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHO

U.S. FDA — Device Enforcement · United States · 2015-02-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1550-2015
Date of alert: 2015-02-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Fresenius Medical Care Holdings, Inc.
Product category: device
Product type: Devices

Reported risk: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

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

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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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