BEUDAMED
    FDA Recall 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 · Initiated June 10, 2013

    Recall

    Recall Number
    Z-1618-2013
    Event Number
    65202
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Product Code
    KMK
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 10, 2013
    Posted
    June 28, 2013
    Terminated
    May 21, 2014
    Address
    605 North 5600, West Salt Lake City, UT, 84116-3738

    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

    Action

    On 6/18/13, an "Urgent Kit Recall" notification letter was mailed to all customers informing them of the recall and instructing the consignee to remove and return any affected product lot numbers to Bard Access Systems through return goods authorization. Customers may contact 800-290-1689 if questions.

    Distribution

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

    Quantity

    3,875 units.