BEUDAMED
    FDA Recall Terminated

    BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (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-1743-2014 · Initiated May 31, 2011

    Recall

    Recall Number
    Z-1743-2014
    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 Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (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 skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.

    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.