BEUDAMED
    FDA Enforcement Class II Terminated

    PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

    Recall: Z-2461-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2461-2018
    Event ID
    80306
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    May 7, 2018
    Classification Date
    July 17, 2018
    Termination Date
    June 8, 2020
    Address
    Us Highway 22 West, Somerville, NJ, 08876, United States

    Description

    PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

    Reason

    The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

    Code Info

    KDH782 KEH344 KEJ158 KGJ668 KGQ354 KJE929 KJH424 KKJ658 LAB267 LCH376 LCH571 LEB803 LGB860 LKR893 LPJ096 LPP510 MCJ449 MCQ993

    Distribution

    Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

    Quantity

    4440