BEUDAMED
    FDA Enforcement Class II 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 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1743-2014
    Event ID
    68313
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioDerm, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 18, 2014
    Initiation Date
    May 31, 2011
    Classification Date
    June 10, 2014
    Termination Date
    June 20, 2014
    Address
    12320 73rd Ct, N/A, Largo, FL, 33773-3011, United States

    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.

    Code Info

    Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.

    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.