Device recall

Z-2227-2010: Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for…

FDA device recall · Class II · Fresenius Medical Care North America

Key facts

Recall number (Z-number) Z-2227-2010
Recall event 54546
Product Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA
Product code FKP
Recalling firm Fresenius Medical Care North America
Recall class Class II
Status Terminated
Termination date Feb 7, 2011
510(k) numbers K921456
FEI number 3001451489

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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