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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

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.
Recall Number Z-1744-2014
Classification Class II
Code Info Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.
Product Distributed Qty 26,040 units.
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.

Event Detail

Event Id 68313
Product Type Devices
Status Completed
Recalling Firm BioDerm, Inc.
City Largo
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-05-31
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.