The Recall Desk

FDA (Devices) recall action 65380

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

TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system.

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

1–2 of 2

  • ModerateFDA (Devices)··2013-08-21

    Terumo Advanced Perfusion System 1 Recalled for False Pressure Alarm

    Terumo is recalling 1,657 Advanced Perfusion System 1 units because a false high-pressure alarm can stop the pump. The company is updating manuals and issuing labeling addenda.

    Product
    100/120V AC, Advanced Perfusion System 1 Product Usage: 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…
    Category
    Distribution
    43 states
  • ModerateFDA (Devices)··2013-08-21

    Terumo Advanced Perfusion System 1 Recall for Pressure Alarm Issue

    Terumo is recalling 1,657 Advanced Perfusion System 1 units to update manuals and address a false high-pressure alarm that can stop the pump.

    Product
    220/240V AC, Advanced Perfusion System 1 Product Usage: 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…
    Category
    Distribution
    43 states