BEUDAMED
    FDA Enforcement Class II Terminated

    KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.

    Recall: Z-0995-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-0995-2013
    Event ID
    64689
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kimberly-Clark Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 3, 2013
    Initiation Date
    March 6, 2013
    Classification Date
    March 26, 2013
    Termination Date
    September 16, 2013
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076, United States

    Description

    KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.

    Reason

    Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.

    Code Info

    Product Code 68507 (Round) Case Lot Numbers MF1284XXX, MF1287XXX, MF1294XXX, MF1316XXX, MF2012XXX, MF2055XXX, MF2086XXX, MF2098XXX, MF2115XXX, MF2146XXX, MF2178XXX, MF2188XXX, MF2196XXX, MF2210XXX, MF2228XXX, MF2243XXX, MF2264XXX, MF2271XXX, MF2285XXX, MF2328XXX, and MF2338XXX. Product Code 68509 (Square) Case Lot Numbers MF1279XXX, MF1287XXX, and MF1288XXX.

    Distribution

    Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, Belgium, Hong Kong, Japan, Portugal, and Singapore.

    Quantity

    Code 68507 - 6420 cases; Code 68509 - 1281 cases