BioDerm, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1744-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: May 31, 2011

Date Posted: June 18, 2014

Recall Number: Z-1744-2014

Event ID: 68313

Reason for Recall:

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.

Status: Terminated

Product Quantity: 26,040 units.

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated