BEUDAMED
    FDA Enforcement Class II Ongoing

    Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)

    Recall: Z-1825-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1825-2022
    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

    Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)

    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

    TSFBP-35-180 (GPN G09782) UDI-DI 00827002097827, Lots 14797763 14797770 14805076 14805079 14813709 14813711; TSFBP-35-145 (GPN G09735) UDI-DI 00827002097353, Lots 14807595 14812037 14812038

    Distribution

    Domestic distribution nationwide. Foreign distribution worldwide.

    Quantity

    488 US, 5 OUS