The Recall Desk

FDA (Devices) recall action 65739

Fresenius Medical Care Holdings, Inc. recalled 3 products on 2013-11-20

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2013-11-20
Critical
0
Units
540,759

Why these products were recalled

Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss

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.

1–3 of 3

  • SevereFDA (Devices)··2013-11-20

    Fresenius Medical Care Recalls Combiset Blood Lines for Hemodialysis

    Fresenius Medical Care is recalling 508,029 cases of Combiset Blood Lines for hemodialysis because connections may disconnect if not tightened correctly, leading to blood loss.

    Product
    Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-11-20

    Fresenius Hemodialysis Blood Lines Recalled for Potential Disconnection Risk

    Fresenius Medical Care is recalling 8,528 cases of 2008K@ Home Blood lines due to a risk of disconnection and blood loss if not tightened correctly.

    Product
    2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-11-20

    Fresenius Medical Care Recalls Combiset Blood Lines for Hemodialysis

    Fresenius Medical Care is recalling 24,202 cases of Combiset Blood Lines with BVM for hemodialysis. The recall addresses a risk of blood loss if connections are not tightened correctly.

    Product
    Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Category
    Distribution
    0 states