BEUDAMED
    FDA Enforcement Class II Ongoing

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    Recall: Z-1711-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1711-2022
    Event ID
    90710
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2022
    Initiation Date
    July 19, 2022
    Classification Date
    September 9, 2022
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    Reason

    Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

    Code Info

    UDI-DI: (01)00827002561618- Lot Numbers: 14095646, 14174879

    Distribution

    Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

    Quantity

    85 units