The Recall Desk

FDA (Devices) recall action 65354

Terumo Cardiovascular Systems Corporation recalled 2 products on 2013-08-21

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
2013-08-21
Critical
0
Units
3,314

Why these products were recalled

The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.

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

  • ModerateFDA (Devices)··2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for Incomplete Operator Manual Instructions

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump behavior during specific alarm conditions.

    Product
    Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-08-21

    Terumo Advanced Perfusion System 1 Recall for Incomplete Operator Manual

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump reactions during specific alarm conditions.

    Product
    Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used b
    Category
    Distribution
    0 states