BEUDAMED
    FDA Recall Terminated

    Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.

    Recall: Z-0295-2018 · Initiated July 18, 2017

    Recall

    Recall Number
    Z-0295-2018
    Event Number
    78360
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    FQM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 18, 2017
    Terminated
    April 24, 2020
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.

    Reason

    Product did not undergo correct sterilization procedures and may potentially be non-sterile.

    Action

    Medline sent a Recall Notification Letter dated July 18, 2017 to affected via USPS 1st Class Mail. The instructions included to check inventory and quarantine affected product, complete and return the response form, arrange return of affected product, and to notify customers if the product was further distributed. For questions contact 866-359-1704.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, WA and the countries of Canada, Saudi Arabia, and Netherlands.

    Quantity

    5,722 units total