BEUDAMED
    FDA Enforcement Class II Terminated

    First Step Draco Pad, Product Number EP-4D

    Recall: Z-1925-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1925-2019
    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

    First Step Draco Pad, Product Number EP-4D

    Reason

    This product has been contaminated with Stenotrophomonas lactiubi.

    Code Info

    Lot Numbers EX20191221X EX20191226X EX20191227X EX20191228X

    Distribution

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

    Quantity

    10570