BEUDAMED
    FDA Enforcement Class II Ongoing

    NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T

    Recall: Z-2083-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2083-2020
    Event ID
    85343
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nelson Innovaions, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 27, 2020
    Initiation Date
    February 11, 2020
    Classification Date
    May 21, 2020
    Address
    18944 W 130th St, N/A, Strongsville, OH, 44136-8427, United States

    Description

    NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T

    Reason

    Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging

    Code Info

    Lot #90971

    Distribution

    CA, NC, PR

    Quantity

    100 units