| Class 2 Device Recall SKINPREP Protective wipes | |
Date Initiated by Firm | May 31, 2011 |
Date Posted | June 10, 2014 |
Recall Status1 |
Terminated 3 on June 20, 2014 |
Recall Number | Z-1742-2014 |
Recall Event ID |
68313 |
Product Classification |
Bandage, liquid, skin protectant - Product Code NEC
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Product | BioDerm Liberty 3.0 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
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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 |
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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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