BEUDAMED
    FDA Recall Terminated

    Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844

    Recall: Z-0970-2020 · Initiated January 4, 2019

    Recall

    Recall Number
    Z-0970-2020
    Event Number
    82026
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    KOE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 4, 2019
    Terminated
    May 29, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844

    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.

    Action

    On January 4, 2019, the firm distributed Urgent Medical Device Recall letters to customers via courier mail. Customers were informed that affected lots may contain a wire guide that was incorrectly loaded into the wire guide holder.

    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