BEUDAMED
    FDA Enforcement Class III Terminated

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

    Recall: Z-2104-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2104-2018
    Event ID
    80086
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Datascope Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 13, 2018
    Initiation Date
    March 11, 2016
    Classification Date
    June 6, 2018
    Termination Date
    June 7, 2019
    Address
    15 Law Dr, N/A, Fairfield, NJ, 07004-3206, United States

    Description

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

    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.

    Code Info

    Batch Number 3000020069, UDI Code 10607567203300; Batch Number 3000021675, UDI Code 10607567203300

    Distribution

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

    Quantity

    19 total kits