BEUDAMED
    FDA Enforcement Class II Ongoing

    Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    Recall: Z-2836-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2836-2020
    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)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - 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: 3000102215 3000102248 3000102249 3000103405 3000103406 3000105261 3000105262 3000106963 3000107331 3000107332 3000108589 3000108881 3000110520 3000111682 3000113810 3000046748 3000102329 3000103404

    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

    29653 kits WW