BEUDAMED
    FDA Recall Terminated

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

    Recall: Z-2106-2018 · Initiated March 11, 2016

    Recall

    Recall Number
    Z-2106-2018
    Event Number
    80086
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    DWE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 11, 2016
    Terminated
    June 7, 2019
    Address
    15 Law Dr, Fairfield, NJ, 07004-3206

    Description

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

    Reason

    There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.

    Action

    Urgent Safety Alert notifications were sent to customers on 3/11/16. The notices included the following instructions for customers: Please examine your inventory immediately to determine if you have the lot/batch numbers listed. If so, please following the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. URGENT: Please complete attached Customer Response Form on page 3, to acknowledge that you have received the Terumo Cardiovascular Systems Urgent Safety Alert. Please fax the completed Customer Response Form to 1-973-396-3607 or send via email to [email protected].

    Distribution

    The products were distributed to the following US states: AL, OR, and TX.

    Quantity

    19 total kits