BEUDAMED
    FDA Recall Terminated

    Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs

    Recall: Z-0518-2014 · Initiated October 24, 2013

    Recall

    Recall Number
    Z-0518-2014
    Event Number
    66859
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    CAZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 24, 2013
    Posted
    December 16, 2013
    Terminated
    August 25, 2017
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076-2190

    Description

    Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs

    Reason

    Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe.

    Action

    Kimberly Clark Corporation sent a Product Advisory Notice letter to affected consignees. The letter identified the affected product, problem and actions to be taken. For questions call 770-587-8393 or via email

    Distribution

    U.S. Nationwide Distribution

    Quantity

    389,300 units