BEUDAMED
    FDA Enforcement Class II Terminated

    StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters.

    Recall: Z-1618-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1618-2013
    Event ID
    65202
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2013
    Initiation Date
    June 10, 2013
    Classification Date
    June 28, 2013
    Termination Date
    May 21, 2014
    Address
    605 North 5600 West, N/A, Salt Lake City, UT, 84116-3738, United States

    Description

    StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters.

    Reason

    BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the cathet

    Code Info

    Lot JUWJF283

    Distribution

    National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).

    Quantity

    3,875 units.