BEUDAMED
    FDA Enforcement Class II Terminated

    Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431

    Recall: Z-1465-2014 · Reported April 23, 2014

    Enforcement

    Recall Number
    Z-1465-2014
    Event ID
    67925
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2014
    Initiation Date
    March 28, 2014
    Classification Date
    April 16, 2014
    Termination Date
    December 12, 2014
    Address
    28 Howe St, N/A, Ashland, MA, 01721-1305, United States

    Description

    Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431

    Reason

    Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits

    Code Info

    Lot Number: RA-27

    Distribution

    CA

    Quantity

    37 units