BEUDAMED
    FDA Enforcement Class II Terminated

    VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144

    Recall: Z-2085-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2085-2019
    Event ID
    83281
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CellEra LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 31, 2019
    Initiation Date
    September 1, 2016
    Classification Date
    July 25, 2019
    Termination Date
    February 9, 2021
    Address
    1045 Reed Dr Ste C, N/A, Monroe, OH, 45050-1717, United States

    Description

    VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144

    Reason

    Adhesive border was not sticky enough.

    Code Info

    Lot # 161616 Cat. No. 20144 HIBCC bar code was M6692014409

    Distribution

    OH, PA, VA

    Quantity

    2110 units