BEUDAMED
    FDA Recall Terminated

    Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS

    Recall: Z-3210-2018 · Initiated June 15, 2018

    Recall

    Recall Number
    Z-3210-2018
    Event Number
    80758
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    MNL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 15, 2018
    Posted
    October 11, 2018
    Terminated
    May 18, 2020
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS

    Reason

    There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.

    Action

    Medline notified customers on about 06/15/2018 via URGENT RECALL MEDLINE INDUSTRIES, INC. IMMEDIATE ACTION REQUIRED letter. Accounts that purchased a custom kit or standard Pack were instructed to immediately check inventory for affected devices, quarantine any affected devices, affix the provided stickers on affected kits and continue use but were instructed to not use the Endoscopic Cleaning Brush in the kit and to instead pull another approved product from inventory. They were also instructed to complete and return the Verification Form. Accounts that just purchased the Endoscopic Cleaning Brush were instructed to immediately check inventory for affected devices, destroy any affected devices, notify customers if the product has been further distributed, and complete and return the provided destruction form listing the quantity of affected products destroyed or that there was no product on hand to destroy.

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY

    Quantity

    183,606 devices total