BEUDAMED
    FDA Recall Terminated

    BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.

    Recall: Z-1744-2014 · Initiated May 31, 2011

    Recall

    Recall Number
    Z-1744-2014
    Event Number
    68313
    Firm
    BioDerm, Inc.
    FEI Number
    3001949129
    Product Code
    NEC
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    May 31, 2011
    Posted
    June 10, 2014
    Terminated
    June 20, 2014
    Address
    12320 73rd Ct, Largo, FL, 33773-3011

    Description

    BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.

    Reason

    On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers.

    Action

    Notice was sent to customers by letter dated June 8, 2011 and by phone.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, NH, NJ, NY, PA, TX, and WI, and the countries of Canada and Netherlands.

    Quantity

    26,040 units.