BEUDAMED
    FDA Enforcement Class III Terminated

    CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

    Recall: Z-0001-2017 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-0001-2017
    Event ID
    75118
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 12, 2016
    Initiation Date
    December 11, 2015
    Classification Date
    October 3, 2016
    Termination Date
    October 26, 2016
    Address
    125 Blue Ball Rd, N/A, Elkton, MD, 21921-5315, United States

    Description

    CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.

    Reason

    Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.

    Code Info

    6912 , 6913 6914, 6932, 6933 6934, 6922, 6923 6924, CV-6912, CV-6913, CV-6914 Cardiovascular Procedure Kits- Various

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution.

    Quantity

    140,000 units