BEUDAMED
    FDA Enforcement Class II Terminated

    Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z

    Recall: Z-1924-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1924-2019
    Event ID
    82971
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Madison Polymeric Engineering
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2019
    Initiation Date
    May 8, 2019
    Classification Date
    July 2, 2019
    Termination Date
    July 6, 2020
    Address
    965 W Main St, N/A, Branford, CT, 06405-3453, United States

    Description

    Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z

    Reason

    This product has been contaminated with Stenotrophomonas lactiubi.

    Code Info

    Lot Numbers EX20191121P EX20191126P EX20191127P EX20191212X EX20191213X EX20200125X

    Distribution

    The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.

    Quantity

    2723