BEUDAMED
    FDA Recall 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 · Initiated May 14, 2012

    Recall

    Recall Number
    Z-1858-2012
    Event Number
    61899
    Firm
    Hartmann USA, Inc
    FEI Number
    1218946
    Product Code
    NAB
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    May 14, 2012
    Posted
    June 22, 2012
    Terminated
    October 6, 2014
    Address
    481 Lakeshore Pkwy, Rock Hill, SC, 29730-4205

    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

    Action

    The firm, HARTMANN USA, sent an "URGENT: RECALL NOTICE" dated May 14, 2012 to its Consignees/Customers. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, block further shipments of affected items and retrieve additional affected stock from their customers; to confirm initial receipt of the notice by emailing [email protected]; complete and return the Affected Products and Stock Levels form via fax to: HARTMANN USA customer service at (1-803-325-7606); contact customer service to obtain a Returned Goods Authorization; and take adequate measures to ensure this notice is distributed appropriately. If you have any further questions or issues related to this recall, please contact HARTMANN USA customer service or your sales representative at 1-800-243-2294 or email: [email protected].

    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