BEUDAMED
    FDA Enforcement Class II Terminated

    Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic

    Recall: Z-0687-2020 · Reported December 25, 2019

    Enforcement

    Recall Number
    Z-0687-2020
    Event ID
    84293
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Southwest Technologies Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 25, 2019
    Initiation Date
    November 18, 2019
    Classification Date
    December 13, 2019
    Termination Date
    August 23, 2024
    Address
    1746 E Levee St, Kansas City, MO, 64116-4404, United States

    Description

    Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic

    Reason

    Elasto-Gel Wound Dressing may be contaminated with mold.

    Code Info

    Lot 1917802

    Distribution

    CA, GA, IL, KS, NY, OH, TN, TX, VA

    Quantity

    3260 eaches (5 eaches per retail box)