The Recall Desk

FDA (Devices) recall action 85310

Fresenius Medical Care Holdings, Inc. recalled 2 products on 2020-04-29

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-04-29
Critical
0
Units
116,805

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2020-04-29

    Fresenius 2008T Hemodialysis Machines Recalled for False USB Alarm

    Fresenius Medical Care is recalling 2008T hemodialysis machines because they may display a false 'Remove USB Device 2' alarm when no USB device is connected.

    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-04-29

    Fresenius 2008T BlueStar Hemodialysis Machines Recalled for USB False Alarm

    Fresenius Medical Care is recalling 15,342 hemodialysis machines because a false alarm may appear when a USB device is connected.

    Product
    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
    Category
    Distribution
    0 states