BEUDAMED
    FDA Enforcement Class II Ongoing

    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    Recall: Z-2847-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2847-2020
    Event ID
    85823
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datascope Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2020
    Initiation Date
    July 27, 2020
    Classification Date
    August 21, 2020
    Address
    15 Law Dr, N/A, Fairfield, NJ, 07004-3206, United States

    Description

    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    Reason

    Potential Endotoxin Contamination

    Code Info

    Kit Lot Number: 3000053317 3000056694 3000057318 3000057970 3000062073 3000062639 3000062640 3000068106 3000071287 3000072717 3000064723 3000072718 3000072719 3000074886 3000087744 3000090528 3000076632 3000078856 3000080307 3000083331 3000084962 3000092774 3000092775 3000095473 3000096376 3000096606 3000096379 3000098751 3000104521 3000115011

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

    Quantity

    3055 Kits