BEUDAMED
    FDA Recall Terminated

    CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.

    Recall: Z-1018-2016 · Initiated January 19, 2016

    Recall

    Recall Number
    Z-1018-2016
    Event Number
    73126
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 19, 2016
    Terminated
    October 24, 2016
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    Description

    CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.

    Reason

    The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.

    Action

    A Safety Alert letter dated January 13, 2015 via registered mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to check the communication of the Cuvette prior to initiating Cardiopulmonary Bypass (CPS). The Terumo Safety Alert did not request removal or return of the product. The instructions that Sarin has communicated to the customers is identical to the information from Terumo. Acknowledgement of the letter and understanding of the contents is required for all customer responses.

    Distribution

    US Nationwide Distribution and Canada.

    Quantity

    6859