BEUDAMED
    FDA Enforcement Class II Terminated

    Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837

    Recall: Z-0960-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-0960-2021
    Event ID
    87087
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 17, 2021
    Initiation Date
    January 4, 2021
    Classification Date
    February 5, 2021
    Termination Date
    September 16, 2021
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837

    Reason

    Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.

    Code Info

    Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897

    Distribution

    FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland

    Quantity

    42 units