BEUDAMED
    FDA Enforcement Class II 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 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0518-2014
    Event ID
    66859
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kimberly-Clark Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    October 24, 2013
    Classification Date
    December 16, 2013
    Termination Date
    August 25, 2017
    Address
    1400 Holcomb Bridge Rd, N/A, Roswell, GA, 30076-2190, United States

    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.

    Code Info

    Lot numbers: 181024, 181129 181217, 181221, 181231, 182022, 182058, 182101, 182108, 182131, 182222, 182223, 182263, 182265, 182289, 182293, 182301, 182315, 181A074, 181A94, 181A154, 181A177, 181A286, 181A289, 181A369, 182A002, 182A005, 182A012, 182A055, 182A056, 182A057, 182A064, 182A074, 182A075/182A78, 182A085, 182090, 182A142, 182AA144, 182A151, 182A155, 182A178, 182A194, 182A196, 182A198, 182A202, 182A204, 182A212, 182A216 and 189A001 (syringe).

    Distribution

    U.S. Nationwide Distribution

    Quantity

    389,300 units