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BioDerm, Inc. recalls BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for app
Recalled June 18, 2014 · FDA recall Z-1744-2014 · BioDerm
Hazard
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. · FDA Class II
Units
26,040 units.
Sold at
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.
Description
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.
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.
Manufacturer(s)
BioDerm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →