BEUDAMED
    FDA Enforcement Class II Terminated

    CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO

    Recall: Z-2947-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2947-2018
    Event ID
    80656
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Civco Medical Instruments Co. Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 5, 2018
    Initiation Date
    July 30, 2018
    Classification Date
    August 29, 2018
    Termination Date
    September 16, 2020
    Address
    102 1st St S, N/A, Kalona, IA, 52247-9589, United States

    Description

    CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO

    Reason

    The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.

    Code Info

    UDI 00841436107334, Lot numbers: A035054, A042207

    Distribution

    United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom

    Quantity

    3 units