BEUDAMED
    FDA Enforcement Class II Terminated

    PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10

    Recall: Z-0962-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0962-2020
    Event ID
    82026
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    January 4, 2019
    Classification Date
    February 4, 2020
    Termination Date
    May 29, 2020
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10

    Reason

    The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

    Code Info

    7832498 7832499 7832500 7925385 7925387 7930517 8090868 8287793 8287794 8287799 8400121 8548813 8548815 NS8548814 7760235 7881599 8062433 8074027 8290383 8290384 8404559 8404562 7999663 8077582 8077583 8065959 8073949 8074014 8074015

    Distribution

    Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.

    Quantity

    3929