The Recall Desk

FDA (Devices) recall action 68313

BioDerm, Inc. recalled 3 products on 2014-06-18

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-06-18
Critical
0
Units
78,120

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2014-06-18

    BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

    BioDerm, Inc. is voluntarily recalling specific skin wipes used in male incontinence devices due to potential bacterial contamination from a contract manufacturer.

    Product
    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.
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2014-06-18

    BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

    BioDerm, Inc. is voluntarily recalling skin-prep wipes used with external male catheters due to potential bacterial contamination.

    Product
    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 ext
    Category
    Distribution
    9 states
  • HighFDA (Devices)··2014-06-18

    BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

    BioDerm, Inc. is voluntarily recalling skin-prep wipes used with external male catheters due to potential bacterial contamination.

    Product
    BioDerm Liberty 3.0 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-inv
    Category
    Distribution
    9 states