BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2083-2020 · Initiated February 11, 2020

    Recall

    Recall Number
    Z-2083-2020
    Event Number
    85343
    Firm
    Nelson Innovaions, Llc
    FEI Number
    3015524870
    Product Code
    NAE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 11, 2020
    Address
    18944 W 130th St, Strongsville, OH, 44136-8427

    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

    Action

    Nelson Innovations, LLC contacted customers on 2/11/20 via phone call to state reason for recall, health risk and request return of affected product and provided call tags for pick-up of product.

    Distribution

    CA, NC, PR

    Quantity

    100 units