BEUDAMED
    FDA Enforcement Class II Terminated

    Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866

    Recall: Z-0963-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0963-2020
    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

    Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866

    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

    7853231 7853232 7853233 7853239 7853240 7853241 7853242 7853243 7853245 7853247 7901140 7901141 7982113 7982118 7982133 8050291 8241613 8241616 8252179 8252181 8252186 8258553 8283322 8407934 8460985 8474895 8474898 8474905 8474906 8474908 8474909 8474910 7936207

    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

    13388 total