BEUDAMED
    FDA Recall Terminated

    MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

    Recall: Z-2018-2012 · Initiated September 17, 2009

    Recall

    Recall Number
    Z-2018-2012
    Event Number
    62451
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    FYA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 17, 2009
    Posted
    July 16, 2012
    Terminated
    July 19, 2012
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076

    Description

    MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

    Reason

    Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

    Action

    Kimberly Clark sent an Urgent Medical Device Recall letter dated September 17, 2009. to all affected consignees. The Recall notification of the expanded recall was sent to consignees on November 17, 2009. Customers were instructed to destroy all affected product remaining in their inventory. For questions regarding this recall call 770-587-7400.

    Distribution

    Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA