The Recall Desk

FDA (Devices) recall action 62315

Terumo Cardiovascular Systems Corporation recalled 6 products on 2012-10-31

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2012-10-31
Critical
0
Units
2,256

Why these products were recalled

Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction

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.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 1,097 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when us
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo is recalling 81 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when us
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 312 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, wh
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when us
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2012-10-31

    Terumo Sarns Modular Perfusion System 8000 Recalled for Power Malfunctions

    Terumo CVS is recalling 466 Sarns Modular Perfusion System 8000 units due to reported power distribution and battery back-up malfunctions.

    Product
    Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, wh
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 26 units of the Sarns Modular Perfusion System 8000 due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when us
    Category
    Distribution
    42 states