BEUDAMED
    FDA Enforcement Class II Terminated

    Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

    Recall: Z-1708-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1708-2016
    Event ID
    73983
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    April 28, 2016
    Classification Date
    May 23, 2016
    Termination Date
    June 29, 2016
    Address
    1810 W Drake Dr, N/A, Tempe, AZ, 85283-4327, United States

    Description

    Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

    Reason

    Mislabeled for size

    Code Info

    Catalog Number: 401450 Lot Number: 2561683E Expiration Date: 5/13/2017 Catalog Number: 401877 Lot Number: 2555866E Expiration Date: 5/6/2017

    Distribution

    Distributed in the state of NY and the country of Canada.

    Quantity

    18 devices