BEUDAMED
    FDA Enforcement Class II Terminated

    Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

    Recall: Z-2211-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2211-2017
    Event ID
    77164
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Madison Polymeric Engineering
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 7, 2017
    Initiation Date
    April 17, 2017
    Classification Date
    June 1, 2017
    Termination Date
    September 21, 2017
    Address
    965 W Main St, Branford, CT, 06405-3453, United States

    Description

    Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

    Reason

    Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.

    Code Info

    Lot Number: EXP20180616 and EXP20180622

    Distribution

    Distributed in the US.

    Quantity

    5 cases