BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2947-2018 · Initiated July 30, 2018

    Recall

    Recall Number
    Z-2947-2018
    Event Number
    80656
    Firm
    Civco Medical Instruments Co. Inc.
    FEI Number
    1937223
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 30, 2018
    Terminated
    September 16, 2020
    Address
    102 1st St S, Kalona, IA, 52247-9589

    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.

    Action

    The firm initiated communication on 07/30/2018 by email and telephone calls. The firm requested return of the recalled product. Questions may be made to the Account Representative by calling CIVCO Medical Solutions, Multi-Modality Imaging at 800-445-6741 or 319-248-6757 7:00 AM - 5:30 PM CST or by email at [email protected]

    Distribution

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

    Quantity

    3 units