Device recall

Z-1027-2017: Fresenius 2008K Series: Hemodialysis System

FDA device recall · Class II · Fresenius Medical Care Renal Therapies Group, LLC

Key facts

Recall number (Z-number) Z-1027-2017
Recall event 76037
Product Fresenius 2008K Series : Hemodialysis System
Product code KDI
Recalling firm Fresenius Medical Care Renal Therapies Group, LLC
Recall class Class II
Status Terminated
Termination date Mar 17, 2023
510(k) numbers K150708
FEI number 3001451489

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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