Medical device recalls Moderate risk

Fresenius Medical Care Holdings, Inc. recalls Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T…

Recall date
March 12, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1749-2020
FDA classification
Class II
Brand / firm
Fresenius Medical Care Holdings, Inc.
Sold / distributed
Nationwide Foreign: Canada, Curaca, Guam

Why it was recalled

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

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

What was recalled

Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR

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