BEUDAMED
    FDA Enforcement Class II Ongoing

    Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534

    Recall: Z-1841-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1841-2022
    Event ID
    90793
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2022
    Initiation Date
    August 16, 2022
    Classification Date
    September 28, 2022
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534

    Reason

    Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

    Code Info

    RPC-35-145 G06979 UDI-DI: 00827002069794 Lots/Expiration Date: 14774168 07-06-2025 14810021 23-06-2025 14813491 27-06-2025 14816228 28-06-2025 14835046 11-07-2025 14835049 11-07-2025 14845506 18-07-2025 NS14813489 27-06-2025 NS14813489X 27-06-2025 RPC-35-80 G09534 UDI-DI: 00827002095342 Lots/Expiration Date: 14823405 01-07-2025 14823407 01-07-2025 14823408 01-07-2025

    Distribution

    Domestic distribution nationwide. Foreign distribution worldwide.

    Quantity

    363 US; 244 OUS