BEUDAMED
    FDA Recall Terminated

    First Step Draco Pad, Product Number EP-4D

    Recall: Z-1925-2019 · Initiated May 8, 2019

    Recall

    Recall Number
    Z-1925-2019
    Event Number
    82971
    Firm
    Madison Polymeric Engineering
    FEI Number
    3001451466
    Product Code
    MNL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 8, 2019
    Terminated
    July 6, 2020
    Address
    965 W Main St, Branford, CT, 06405-3453

    Description

    First Step Draco Pad, Product Number EP-4D

    Reason

    This product has been contaminated with Stenotrophomonas lactiubi.

    Action

    Urgent Medical Device Recall notification letters dated 5/8/19 were sent to customers.

    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