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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 Recall
SKINPREP Protective Wipes
see related information
Date Posted June 10, 2014
Recall Status1 Terminated on June 20, 2014
Recall Number Z-1744-2014
Recall Event ID 68313
Product Classification Bandage, Liquid, Skin Protectant - Product Code NEC
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.
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, Florida 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 (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 Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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