BEUDAMED
    FDA Enforcement Class II Ongoing

    Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268

    Recall: Z-1828-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1828-2022
    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

    Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268

    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

    THSF-35-145-COONS G02356 UDI-DI 00827002023567 Lot/Expiration Date 14757818 27-05-2027 14795059 15-06-2027 14797781 16-06-2027 14802363 20-06-2027 THSF-38-145-COONS G02324 UDI-DI 00827002023246 Lot/Expiration Date 14793057 14-06-2027 THSF-35-180-COONS G02621 UDI-DI 00827002026216 Lot/Expiration Date 14797773 16-06-2027 THSF-35-80-COONS G12268

    Distribution

    Domestic distribution nationwide. Foreign distribution worldwide.

    Quantity

    1,236 US