The Recall Desk

FDA (Devices) recall action 61231

Terumo Cardiovascular Systems Corporation recalled 3 products on 2012-07-18

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
2012-07-18
Critical
0
Units
2,735

Why these products were recalled

Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.

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

  • ModerateFDA (Devices)··2012-07-18

    Terumo Advanced Perfusion System 1 Gas System Recall for Flow Control Issues

    Terumo is recalling 1,095 units of the Advanced Perfusion System 1 Electronic O2 Blender/Analyzer due to reported difficulty adjusting the local flow control knob.

    Product
    Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-07-18

    Terumo Advanced Perfusion System 1 Gas System Recall

    Terumo is recalling 648 Advanced Perfusion System 1 units because users reported difficulty adjusting the gas system flow control knob.

    Product
    Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 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 used…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-07-18

    Terumo Advanced Perfusion System 1 Gas Control Recall

    Terumo is recalling 992 Advanced Perfusion System 1 units due to reported difficulty adjusting the gas flow control knob.

    Product
    Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 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…
    Category
    Distribution
    0 states