Medical device recalls Moderate risk

Fresenius Medical Care Holdings, Inc. recalls ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hem…

Recall date
December 16, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1015-2015
FDA classification
Class II
Brand / firm
Fresenius Medical Care Holdings, Inc.
Sold / distributed
Distributed in OK and FL.

Why it was recalled

Unqualified power assemblies shipped to customers.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System

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