BEUDAMED
    FDA Recall 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 · Initiated March 6, 2013

    Recall

    Recall Number
    Z-0995-2013
    Event Number
    64689
    Firm
    Kimberly-Clark Corporation
    FEI Number
    1000015879
    Product Code
    FRG
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 6, 2013
    Posted
    March 26, 2013
    Terminated
    September 16, 2013
    Address
    1400 Holcomb Bridge Rd, Roswell, GA, 30076

    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.

    Action

    All US distributors and clinics were sent an Urgent: Voluntary Product Recall letter via Federal Express, and the Canadian importer/distributor was also notified with the same letter via Federal Express and e-mail. Distributors were instructed to contact their customers by sending a copy of the letter. The letter identified the affected product and stated the reason for the recall. The recall notification includes a Response Sheet that allows the customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. The customer is instructed to immediately cease further distribution of the product, physically quarantine and destroy the product, and fax the completed Response Sheet to the Kimberly-Clark Recall Coordinator.

    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