The Recall Desk

FDA (Devices) recall action 62444

Terumo Cardiovascular Systems Corporation recalled 2 products on 2012-08-15

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
2012-08-15
Critical
0
Units
1,641

Why these products were recalled

Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re

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

  • HighFDA (Devices)··2012-08-15

    Terumo Advanced Perfusion System 1 Recall for Module Malfunctions

    Terumo is recalling 992 Advanced Perfusion System 1 units due to faulty components in the Occluder and Air Bubble Detection modules.

    Product
    System 1 base 100/120V 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 a qualified perfusionist who is experienced in the oper
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-08-15

    Terumo Advanced Perfusion System 1 recalled for module malfunctions

    Terumo is recalling 649 Advanced Perfusion System 1 units worldwide due to faulty components in the Occluder and Air Bubble Detection modules.

    Product
    System 1 base 220/240V 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 a qualified perfusionist who is experienced in the oper
    Category
    Distribution
    0 states