Reported Jun 18, 2014 · Terminated
BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for…
BioDerm, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioDerm, Inc. · 12320 73rd Ct · Largo, FL · 33773-3011
Is this the product you have?
- BioDerm Safe n' Dry 21006 (ComponentSKIN-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
- Lot codes and dates
- Lot CodesRange from U24401 through U29801
- Model Numbers
23046230362104621036. 21026 and 21006
- Amount recalled
- 26,040 units.
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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