BEUDAMED
    FDA Enforcement Class II Terminated

    Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

    Recall: Z-2203-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2203-2019
    Event ID
    83323
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    April 25, 2019
    Classification Date
    August 6, 2019
    Termination Date
    December 16, 2020
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

    Reason

    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.

    Code Info

    KIT NUMBERS: DYK1002DBDE, DYK1002DBSE, DYK1002DCB, and DYK1002SBC. LOT NUMBERS: GM10, GJ25, HA05, and HA20

    Distribution

    US Nationwide distribution in the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KY, LA, MO, NC, NH, NJ, NM, NY, NV, OH, OK, PA, RI, TN, TX, UT, WV, and WY

    Quantity

    22204