The Recall Desk

FDA (Devices) recall action 70574

Fresenius Medical Care Holdings, Inc. recalled 4 products on 2015-05-06

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2015-05-06
Critical
0
Units
—

Why these products were recalled

The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.

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

1–4 of 4

  • ModerateFDA (Devices)··2015-05-06

    Fresenius 2008 Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008 Series Hemodialysis Machines because the Acetate value for GranuFlo is displayed incorrectly on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-05-06

    Fresenius 2008K Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008K hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC
    Category
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    0 states
  • HighFDA (Devices)··2015-05-06

    Fresenius 2008K2 Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008K2 hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 1
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    0 states
  • ModerateFDA (Devices)··2015-05-06

    Fresenius 2008T Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008T hemodialysis machines because the Select Concentrate screen incorrectly displays the GranuFlo acetate value as 4mEq/l instead of 8mEq/l.

    Product
    2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008
    Category
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    0 states