BEUDAMED
    FDA Enforcement Class II Terminated

    First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3

    Recall: Z-1895-2018 · Reported May 30, 2018

    Enforcement

    Recall Number
    Z-1895-2018
    Event ID
    79826
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Madison Polymeric Engineering
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 30, 2018
    Initiation Date
    March 21, 2018
    Classification Date
    May 18, 2018
    Termination Date
    April 9, 2019
    Address
    965 W Main St, N/A, Branford, CT, 06405-3453, United States

    Description

    First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3

    Reason

    The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

    Code Info

    Lot Numbers: EX20190105P, EX20190108P, EX20190109P, EX20190110P

    Distribution

    The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.

    Quantity

    115 cases/11500 kits