BEUDAMED
    FDA Enforcement Class II Terminated

    MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, 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-2017-2012 · Reported July 25, 2012

    Enforcement

    Recall Number
    Z-2017-2012
    Event ID
    62451
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kimberly-Clark Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2012
    Initiation Date
    September 17, 2009
    Classification Date
    July 16, 2012
    Termination Date
    July 19, 2012
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076, United States

    Description

    MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, 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.

    Code Info

    Product Code: 92340 (Large), Lot #AH9103, AH9110, AH9139, AH9140, AG9154, AH9155 and AH9160; Product Code: 92342 (X-Large), Lot #AH9116, AH9142, AH9143, AH9145, AH9150, AH9151, AH9155, AH9157, AH9159, AH9160, AH9166, AH9168 and AH9076. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number 92340 (Large), Lot numbers: AH9072, AH9073, AH9074, AH9103, AH9140 and AH9146; Product number: 92342 (X-Large), Lot numbers: AH9073, AH9074, AH9112, AH9158, AH9160, AH9163, AH9165, AH9167 and AH9168; Product number: 92344 (XX-Large), Lot numbers: AH9074, AH9139, AH9152, AH9153, and AH9155; Product number: 92353 (X-Large Specialty), Lot numbers: AH9143, AH9146 and AH9160 and Product number: 92357 (XX-Large Specialty), Lot number range AH9072xxx to AH9175xxx.

    Distribution

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

    Quantity

    79,941 units