Fresenius Medical Care Holdings, Inc. recalls Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 19071

Recalled April 29, 2020 · FDA recall Z-1748-2020 · Fresenius Medical Care Holdings

Hazard

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 · FDA Class II

Units

101,463

Sold at

Nationwide Foreign: Canada, Curaca, Guam

Description

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

Product

Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN

Manufacturer(s)

Fresenius Medical Care Holdings, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →