BEUDAMED
    FDA Enforcement Class II Terminated

    Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing

    Recall: Z-1858-2012 · Reported July 4, 2012

    Enforcement

    Recall Number
    Z-1858-2012
    Event ID
    61899
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hartmann USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2012
    Initiation Date
    May 14, 2012
    Classification Date
    June 22, 2012
    Termination Date
    October 6, 2014
    Address
    481 Lakeshore Pkwy, Rock Hill, SC, 29730-4205, United States

    Description

    Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing

    Reason

    Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products

    Code Info

    Item # 56910000 (Sterilux): 102147399, 102250396, 200105390, 200206394

    Distribution

    Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.

    Quantity

    Lot 102147399 - 421 Cases; Lot 102250396 - 360 Cases; 200105390 - 522 Cases; 200206394 - 390 Cases