BEUDAMED
    FDA Recall Terminated

    StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock PICC Plus and StatLock CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.

    Recall: Z-0982-2017 · Initiated December 9, 2016

    Recall

    Recall Number
    Z-0982-2017
    Event Number
    75908
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Product Code
    KMK
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 9, 2016
    Posted
    January 10, 2017
    Terminated
    May 26, 2017
    Address
    605 N 5600 W, Salt Lake City, UT, 84116-3738

    Description

    StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock PICC Plus and StatLock CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.

    Reason

    Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).

    Action

    Bard sent an Urgent Customer Notification letter dated December 12, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and identify any product subject to the notification. Please direct any return requests and/or questions to Shelly Gilbert at 1-800-290-1689.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    14,500 units total