BEUDAMED
    FDA Enforcement Class II Ongoing

    Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01

    Recall: Z-2842-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2842-2020
    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)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01

    Reason

    Potential Endotoxin Contamination

    Code Info

    Kit Lot Number: 3000051381 3000053316 3000057969 3000062074 3000066987 3000062557 3000062558 3000066988 3000064524 3000066989 3000066990 3000067890 3000069733 3000074397 3000074398 3000077670 3000077671 3000078857 3000080306 3000080310 3000083334 3000083335 3000084272 3000084969 3000087490 3000087491 3000092779 3000092780 3000095470 3000096586 3000098053 3000098054 3000098055 3000098056 3000099590 3000099591 3000112273 3000107761 3000107762 3000112274

    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

    3059 Kits