BEUDAMED
    FDA Enforcement Class III Terminated

    LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

    Recall: Z-2568-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2568-2014
    Event ID
    69072
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Datascope Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    August 11, 2014
    Classification Date
    September 3, 2014
    Termination Date
    February 5, 2015
    Address
    15 Law Dr, Fairfield, NJ, 07004-0011, United States

    Description

    LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group

    Reason

    During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.

    Code Info

    Part Number - 0684-00-0480-01U

    Distribution

    US Distribution to TX.

    Quantity

    one unit