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U.S. Department of Health and Human Services

Class 2 Device Recall SKINPREP Protective wipes

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  Class 2 Device Recall SKINPREP Protective wipes see related information
Date Initiated by Firm May 31, 2011
Date Posted June 10, 2014
Recall Status1 Terminated 3 on June 20, 2014
Recall Number Z-1743-2014
Recall Event ID 68313
Product Classification Bandage, liquid, skin protectant - Product Code NEC
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 external, non-invasive and nonsterile device.
Code Information Lot Codes: Range from U24401 through U29801;  Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.
Recalling Firm/
Manufacturer		 BioDerm, Inc.
12320 73rd Ct
Largo FL 33773-3011
For Additional Information Contact Steve Babb
727-507-7655
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Material/Component Contamination
Action Notice was sent to customers by letter dated June 8, 2011 and by phone.
Quantity in Commerce 26,040 units.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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