The Recall Desk

FDA (Devices) recall action 68042

Fresenius Medical Care Holdings, Inc. recalled 2 products on 2014-05-21

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
2014-05-21
Critical
0
Units
118

Why these products were recalled

2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump

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

  • SevereFDA (Devices)··2014-05-21

    Fresenius Hemodialysis Machine Test Boards Recalled for Pump Detection Failure

    Fresenius Medical Care is recalling Revision K Actuator Test Boards for 2008-Series Hemodialysis Machines because they may fail to detect a disconnected Ultrafiltration Pump.

    Product
    Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-05-21

    Fresenius Hemodialysis Machines Recalled for Potential UF Pump Detection Failure

    Fresenius Medical Care is recalling 79 hemodialysis machines and replacement parts because they may fail to detect a disconnected Ultrafiltration (UF) Pump.

    Product
    Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
    Category
    Distribution
    0 states