The Recall Desk

FDA (Devices) recall action 68024

Terumo Cardiovascular Systems Corporation recalled 3 products on 2014-07-23

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
2014-07-23
Critical
0
Units
256

Why these products were recalled

During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.

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

  • HighFDA (Devices)··2014-07-23

    Terumo Cardiovascular Procedure Kit Recall for Pumphead Leaks

    Terumo is recalling 256 Cardiovascular Procedure Kits because leaks were detected on the centrifugal pumphead during set-up and priming of the bypass circuit.

    Product
    Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230,
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-07-23

    Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks

    Terumo is recalling Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.

    Product
    Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-07-23

    Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks

    Terumo is recalling specific lots of Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.

    Product
    Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
    Category
    Distribution
    0 states