BEUDAMED
    FDA Enforcement Class III Terminated

    ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

    Recall: Z-2425-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2425-2012
    Event ID
    62577
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kimberly-Clark Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    December 31, 2010
    Classification Date
    September 20, 2012
    Termination Date
    November 1, 2012
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076, United States

    Description

    ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

    Reason

    The impacted product was not intended for commercial distribution to end users.

    Code Info

    Product Code: 95221-35, Unit Code: 90372

    Distribution

    US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.

    Quantity

    32 cases