The Recall Desk

FDA (Devices) recall action 62684

Terumo Cardiovascular Systems Corporation recalled 4 products on 2012-08-29

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2012-08-29
Critical
0
Units
1,427

Why these products were recalled

Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modu

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

1–4 of 4

  • SevereFDA (Devices)··2012-08-29

    Terumo Serial Interface Module Recalled for Data Loss and Smoke Odor

    Terumo is recalling 579 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions involving data loss and smoke odor.

    Product
    Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data…
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2012-08-29

    Terumo Advanced Perfusion System 1 Serial Interface Module Recall

    Terumo is recalling 34 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions and smoke odor.

    Product
    Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data…
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2012-08-29

    Terumo Interface Module Recall for Data Transfer Malfunctions

    Terumo is recalling 232 interface modules for the CDl System 100/101 due to reported data transfer malfunctions and smoke odors.

    Product
    Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data…
    Category
    Distribution
    39 states
  • SevereFDA (Devices)··2012-08-29

    Terumo Interface Module for CDl System 500 Recalled for Malfunctions

    Terumo is recalling Interface Modules for the CDl System 500 due to reported malfunctions involving loss of data transfer and smoke odor.

    Product
    Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from…
    Category
    Distribution
    39 states