BEUDAMED
    FDA Enforcement Class II Ongoing

    MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

    Recall: Z-1685-2022 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1685-2022
    Event ID
    90684
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datascope Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2022
    Initiation Date
    August 5, 2022
    Classification Date
    September 8, 2022
    Address
    15 Law Dr, N/A, Fairfield, NJ, 07004-3206, United States

    Description

    MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

    Reason

    Certain lots containing undersized dilator.

    Code Info

    Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567109619, 3000184437, 0684-00-0296-01U; 10607567107301, 3000171501, 0684-00-0498-01; 10607567107301, 3000183312, 0684-00-0498-01; 10607567107301, 3000183313, 0684-00-0498-01; 10607567107301, 3000186654, 0684-00-0498-01; 10607567107301, 3000186655, 0684-00-0498-01.

    Distribution

    Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

    Quantity

    10,427 units