BEUDAMED
    FDA Enforcement Class II Terminated

    SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006

    Recall: Z-1968-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1968-2021
    Event ID
    87999
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spes Medica
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 7, 2021
    Initiation Date
    April 8, 2021
    Classification Date
    June 25, 2021
    Termination Date
    May 10, 2022
    Address
    Via Buccari 21, N/A, Genoa, N/A, N/A, Italy

    Description

    SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006

    Reason

    The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

    Code Info

    Lot UR20F2702I

    Distribution

    Distribution in the following US states: CA, MA, and SC.

    Quantity

    34 boxes