BEUDAMED
    FDA Recall Terminated

    Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape.

    Recall: Z-2836-2011 · Initiated June 6, 2011

    Recall

    Recall Number
    Z-2836-2011
    Event Number
    59161
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 6, 2011
    Posted
    July 21, 2011
    Terminated
    October 14, 2011
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076

    Description

    Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape.

    Reason

    Metal shavings were found within the folded portion of the surgical drape.

    Action

    Kimberly-Clark Corporation sent an "Urgent: Voluntary Product Recall" letter dated June 6, 2011 to all affected customers and a subsequent letter dated June 22, 2011. The letter notified them of the recall and provided recommendations. They were instructed to evaluate their facilities unused inventory of the affected drapes to determine if any of the impacted product lots remain with their facility. If present, they were to quarantine and discontinue use. A Customer Product Recall Response Form was included to be completed and faxed to KC. They will be contacted by a representative regarding the return and replenishment of the product. If the product was further distributed, the consignee was advised to contact the end user, make them aware of the recall and to retrieve any of the affected product in inventory. For additional information please contact Kimberly-Clark Regulatory Affairs at 770-587-7400.

    Distribution

    Nationwide (USA) distribution, including the states of CA, FL, GA, IA, IL, MO, NC, NY, OH, TN, TX, VA and WI.

    Quantity

    223 cases (300 units per case)