BEUDAMED
    FDA Enforcement Class II Terminated

    MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product 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-0258-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0258-2013
    Event ID
    63598
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kimberly-Clark Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    July 5, 2012
    Classification Date
    November 7, 2012
    Termination Date
    June 13, 2013
    Address
    1400 Holcomb Bridge Rd, N/A, Roswell, GA, 30076, United States

    Description

    MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product 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

    Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

    Code Info

    Product Code 92042 - All lot numbers beginning with: AH9282*** to AH9309***, AH0013*** to AH0329***, AH1020 *** to AH1293***, AH2019*** to AH2175***

    Distribution

    Nationwide Distribution

    Quantity

    933 ((30 units per case)